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Best Use of Naukari Portal for Pharma Jobs

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Best Use of Naukari Portal for Pharma Jobs

There are many job portals in India but Naukari.com covers 70 percents market share so you must upload your resume and details here. Many Freshers and experienced professionals get jobs through this portals so take it quite seriously. This blog does not tell you about how to upload the resume and each information in Naukari portal but will guide you to avoid mistakes which are quite avoidable in key fields.

www.naukri.com: Please check your resume if below fields are properly filled.

Profile Photo:
People often postpone upload of Photo that decreases the profile visibility and credibility. You must upload a Professional photograph. 

Resume Headline:
As per Naukari.com; “It is the first thing recruiters notice in your profile. Write concisely what makes you the unique and right person for the job you are looking for.”

Recruiters do not have much to read complete resume so an impressive headline can get you noticed quicker.
In this section, you have to summarize your profile in 250 words.

You can follow the below templates to write resume headlines.
Freshers: https://www.naukri.com/blog/resume-headline-for-freshers/
Experienced Professionals:
https://www.naukri.com/blog/resume-headline-examples-for-naukri/

Skills:
You must include all the related job skills in this section. Maximum limit is 250 characters including commas. Naukri job portal recommends job-based on skills.
Freshers can include the below skills:

For Pharmacovigilance: ICSR, PSUR, DSUR, Aggregate Report Writing, Medical Writing, Clinical Research, PV or Pharmacovigilance

For Medical Writing: DSUR, Protocol, Abstract, PSUR, aggregate report writing, IB, clinical research, CSR, Medical Writing

For Scientific Writing: Scientific writing, Abstracts, Poster, Slides 

Competitive Intelligence: Competitive Intelligence, Market Research, Secondary Research

Health Economics and Outcome Research (HEOR): HEOR, Clinical Research, HTA (Health Technology assessments), Systemic Review

Clinical Data Management: CDM, Clinical Research, Clinical Data Management

Clinical research associate: CRA, Clinical Research, Site Monitor

Clinical research coordinator: CRC, Clinical Research, Clinical Research Coordinator

Medical Coding: Medical Coding, ICD10, MedDRA Dictionary, Clinical Research

Clinical Record Management: eTMF, Clinical Research, Clinical Record Management

Centralised monitoring: CRA, Risk-based monitoring, Clinical Research, Centralised Monitoring

Regulatory affairs: Regulatory affair and clinical research, NDA submission, sNDA submission, Biosimilar, USFDA, EMA

Research and development: HPLC, NMR, Invivivo testing, table, capsules, etc as per your specialization like Pharmacology, Pharmaceutics, Medicinal Chemistry etc

SAS programmers: SAS, ADAM, SDTM, Clinical research

Forecasting: Forecasting, Market Research, Excel

Pricing analyst: Secondary Research, Market Research, Pricing

Data Scientist: The languages you know (Python, SAS, R) and associated skills, Data analyst, Data Scientist

Ther are many common skills which can be added.

Microsoft Excel, Word and PPT, ” Teamwork, Ability to Solve Problems, Skills to Plan and Organize, Analysing Skills, Ability to Create Reports, Skill to Adapt to Changes, Ability to Research, Skills to Manage Projects”

The above list is just for overview and one should read the job description of your desired jobs and add the skills accordingly to get the recruiter call but needless to mention that you need to get those skills to get the job.

 Profile Summary:
It is a summary of your career, education, your professional interest and what kind of job you are looking for. You have to conclude this in 50 characters.

Complete Guide for writing effective Pharma- Resume: Your First Impression

Complete Guide: How to Search and get the job in Pharma and CRO industry

The Best compilation of all job options in Pharmaceutical and CRO industries: Must read for freshers.

Complete Guide for writing effective Pharma- Resume: Your First Impression

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Complete Guide for writing effective Pharma- Resume: Your First Impression

Resume is very important as it is the first opportunity of making an impression on the recruiter’s mind. If you are skilled but do not know how to draft the best resume then you will stand among non-skilled crowed despite being a skilled person. A well-written resume can decrease the number of days or even months of wait from getting a first interview call.

I will guide you on how you can create the best resume.
You have to remember below points while writing your resume:

  1. Template and one-page rule
  2. Choose the right Fonts
  3. Correct Spelling/Grammar and free tool to write effectively.
  4. Components of Resume

Template and one-page rule: 

Generally, students take their colleagues or seniors resumes and just change a few things and use this resume for personal use. By doing this, You will never come to know how well you could have drafted the best resume.

Just give 5 hours of your life to learn the best resume writing skills. it will help you not only in your first Job and but rest of your life.

You should use a professional clean-resume temple to create your resume. There are many websites and youtube channels which can guide to select and create a wonderful template.   But templet should not be too fancy, it should look professional. Be a little creative. The background should be white and clean.

You can also use Google Image to See the various clean resume template and you can create your known (don’t purchase anything)

If you are fresher it should not be more than one page long. I call it one-page rule as nobody has time to read two pages or more and if it is properly drafted, one page is more than sufficient.

If you are an experienced professional, then you can try not to exceed two pages. (Though One-page rule apply here also)

Choose the right Fonts:

Times new roman can be used if a resume is used in the paper. But this font is not good for the screen view.

Sans serif fonts are preferred as they can be read easily on the screen. Calibri, Gautomi, or Verdana are examples of this category.

Size of font can vary in different segments of the resume but should be same in the same segment. Optimum font size is 10-12 points.

For example, if you use 12 points size-Bold Calibri for first heading, then all heading should be written in the same font-size.

You can use two or three colours, especially which are not much intense as Red. 
Header, subheader, Bullets, boarder can have the colour or they can be bold as well.

Correct Spelling/Grammar and free tool to write effectively:

Needless to mention that spelling mistakes should not be in the resume. Better you writer on Grammarly. It is free to use.
www.grammarly.com. 

Components of Resume:

1.1 Contact section: This section should be at the top of the resume and include the below details:

Photo-Professionally dressed
Name of the Applicant
Contact number
Email Address
Address
It is important to mention the name should be written in a bigger font than the rest of the contact details

1.2 Objective: Experienced professional can use Professional summary instead of objective but fresher can write an objective.

The objective must be tailored according to the job description.

1.3 Professional experience: Experienced professional should include their professional experiences here. It should follow the chronological order (starting from the latest).

Though your professional experiences can not be changed; but you have to make sure you include certain keywords in your resume that are mentioned in the Job description. (Tailoring of the resume as per need).
Freshers do not need to add this section.

1.4 Education: Mention all your educations starting from the 10th class or high school onwards. It should follow the chronological order (highest to lowest). Passing year, institute details and the scores should be mentioned along with degree/diploma details

you can also add your certifications here.
Fresher can include Project or any training related details here.
Object, Professional summary, Professional details, Education are the main body of any resume.

1.5 Skills: Customize the skills section to match as closely as possible the requirements listed in the job posting. A close match can increase the chances of being selected for an interview. You can add the proficiency level of that skills, though it is not mandatory.; but it can have a good impact.

1.6 Languages: Add the languages and proficiency levels but add English proficiency level should be 100 per cent

How to trim your resume to one Page:

This is important especially for experienced professionals. You can achieve this by following ways

  • You can add short sentences instead of explaining each thing. Focus on those things which are more relevant to the job description.
  • Abbreviation for well-known words eg. PSUR for a periodic safety update report etc
  • Do not include academic project details, any academic certification or conference details.

You can send your resume in Microsoft Word or PDF format. Generally, Microsoft word format is preferred.

Complete Guide: How to Search and get the job in Pharma and CRO industry

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Complete Guide: How to Search and get the job in Pharma and CRO industry

Almost all Life Science students face the same problem: “How to Search and get the job in Pharma and CRO industry.

In this blog, I will focus on addressing this problem and will guide you about the ultimate solution. I have divided my answer into 7 parts. If you follow these steps to address your problem, I guarantee your success. They are listed below:

  1. Awareness about job profiles in the Pharmaceutical and CRO industries
  2. Know your interest
  3. Identify the weaknesses and strengths
  4. Develop the required skills
  5. Make connections and update your profile in LinkedIn
  6. Resume
  7. Proper use of job search portal

1. Awareness about job profiles in the Pharmaceutical and CRO industries:

There is always a big gap between the academic curriculum and what we do in industries.
You must know about all job profiles in the Pharma-market.

And it is not easy to read each and everything about job profiles, but at least you can read about overview. Please read the below blog for primary understanding about various job profiles.

The Best compilation of all job options in Pharmaceutical and CRO industries: Must read for freshers

After reading the above blog, you have to do two things:

  • Please google each job profile mentioned in the above blog and read the relevant documents and develop an understanding.
  • You can search the job profiles in Job search portals such as Naukri, Monster etc. In this way, you get to know not only about exact job profiles and the nature of work but also the essential requirements of those profiles.

2. Know your interest:

Few people are interested in just making money and they can work in any profile as long as it pays well. On the other hand, few people are passionate about particular work and they do not bother much about whether it pays good or average.

You have to remember one thing: the job profiles, you like, may not be among the highest paying jobs in Pharma and CRO industries and vice versa is also true.

There is also enough possibility that you like the job profile and get good money as well.

I tell you the simple logic: job profiles which require strong technical skills or associated with direct revenue generation for the company, are among the one which pays more. for example Data Scientist, Statistics etc. Forecasting, Market Research analyst etc.

How to know your interest:
It sounds weird that I am asking” how to know your interest”. But Everybody does not know about their interest.
Don’t worry about this because the solution is very simple; just you need to read a lot about different job profiles.

So the first step (Awareness about job profiles in the Pharmaceutical and CRO industries) can solve this problem only thing you need to read a little bit more. Also, you can connect with those individuals who are working in that particular field.

Interests changes over time, it may become deeper for the same profile or you may start liking a different job profile after two-three years of working (even more years). Change in interest may be due to the nature of work or money involved in it.

3. Identify the weaknesses and strengths :

Now you know your interest, so you can evaluate yourself, what is your weakness and strength.

Suppose you like Data science (your interest) but you are poor in analytical thinking (weakness) but you are not zero about programming (strength

Knowing weakness is an opportunity to learn and knowing strength is necessary to have confidence.

This introspection can help you to learn and acquire essential skills for that particular job profile.

Below mentioned skills are quite common and everyone must have those. So while evaluating yourself, consider below two skills set as well.

Communication: The bitter truth, you can not grow without this skill in any profile.  

Basic Excel, Presentation and Microsoft word: This is the second most important thing and come under “essential skills”

Develop the required skills:

Once you know your weakness and strength, you need to work on improving those things which are lacking. You can follow the below suggestions:

  1. Talk to your seniors or any connection about your weakness and seek guidance.
  2.  There are many youtube tutorials are available, you can follow them
  3. You can join the relevant course online or offline
  4. Read more and if any suggestion/guidance is needed then:

You can write to us at [email protected]

Note: It is important to mention that many organisation conduct the aptitude test, so it is better to practice them.

4. Make connections and update your profile in LinkedIn 

  • I will suggest you make connection quite consciously. You should connect with those individuals more; who are working in your interest area. 
  • While sending a connection request, please write the appropriate message. Don’t hesitate to seek guidance.
  • Update your profile completely in such a way that it should be all-time ready. Mention your skills properly. You can ask for recommendations.
  • The last but important. try to connect with HR personnel

5. Resume Building and Proper use of job search portal

Please follow these two blogs for this segment:

Complete Guide for writing effective Pharma- Resume: Your First Impression

Best Use of Naukari.com for Pharma Jobs

FDA approves Life-changer for all childrens with peanut allergies

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FDA approves Life-changer for all childrens with peanut allergies

Jan 31, 2020: The first treatment for peanut allergies is about to hit the market, developed by Aimmune Therapeutics, a big step toward better care for all kinds of food allergies — but still a long way from a cure.

Food and Drug Administration promises to bring some aid to families who have lived in fear of an accidental bite of peanuts at birthday parties and play dates, school cafeterias and restaurants.

The treatment is a particularly prepared peanut powder swallowed daily in tiny amounts that are gradually increased over months.

It trains children’s and teens’ bodies to better tolerate peanut so that an accidental bite is less likely to cause a severe reaction, or even kill in severe cases. Palforzia users still must avoid peanuts as they always have.

Also, the treatment is not for everyone. Palforzia can cause side effects that includes  occasional severe allergic reactions.

The FDA is requiring that doctors and their patients enroll in a special security program, and patients must take the first dose and each increased dose under supervision in a certified health center.

Shots have long been used in order to induce tolerance for allergies to be stings or pollen. But swallowing an allergen to build tolerance is a new wind — one that scientists call “oral immunotherapy.”

And the peanuts are just the first food to be tackled. Tests for eggs, milk and tree nuts are in progress.

FOOD ALLERGY IS A RISING PROBLEM: Millions of the Americans have food allergies together with about 1 in 13 children, and the numbers have increased in recent years.

Peanut allergy is most common one between children, and with the most dangerous. Accidental exposures are normal, with about 1 in 4 affected children twisting up in the emergency room every year.

WHAT HAPPENS: “The immune system overreacts to food by triggering an inflammatory cascade. On average, children can experience rash, wheezing or worse from just a 30th of a single peanut, sometimes even less.”Until now, all doctors could advise was to read food labels and avoid anything that might contain unknown peanuts. Decades ago, attempts at shots were believed too risky for food allergies.

HOW IT WORKS: Doctors prescribe a miniscule Palforzia powder as starting dose, stored in a capsule, is mixed into any unheated food, such as Nichols’ favorite fruit smoothies. Patients take the first dose in a doctor’s office, in case of the bad allergic reaction.

In every few weeks, the dose increased until after about six months, they’re taking the equivalent of about one peanut. In a study of nearly 500 children, two-thirds who received Palforzia could eat the equivalent of two peanuts — and some can even three or four — compared to just 4% of patients given a mannequin drug.

THE WARNINGS: Palforzia users still must carry their salvage medicine, such as EpiPens, in order to treat severe allergic reactions. Most experience at least mild side effects, such as hives or stomachaches, and concerning a fifth dropped out of the study, said Dr. Scott Sicherer, a pediatric allergist at Mount Sinai Hospital in New York. As for severe reactions, they struck about 9% of the patients treated in the Palforzia study, almost three times the number in the placebo group and prompting debate about the drug’s usefulness.

OTHER ALLERGY TREATMENTS IN THE PIPELINE ARE:

  • DBV Technologies’ Viaskin is a daily patch that contains small amounts of the peanut protein absorbed through the skin, in hopes of less side effects.
  • Allergen drops under the tongue are in the early-stage testing but demonstrate promise in a recent study from the University of North Carolina, Chapel Hill.
  • Shots to block allergic reactions deliver antibodies that pack down the inflammatory cascade that follows accidental exposure. A Stanford University pilot study suggested that a single shot could block a peanut reaction for two to six weeks. https://fda.einnews.com/article/508616144?lcf=8DWPqPuUsDVNDakfEIxsCA%3D%3D

WuXi Biologics gives Operation Update Related to the Coronavirus Outbreak

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WuXi Biologics gives Operation Update Related to the Coronavirus Outbreak

Jan 30, 2020: The coronavirus outbreak is having a potentially considerable social and economic impact in China.4

WuXi Biologics is directly monitoring the coronavirus outbreak and is complying with guidance from the relevant authorities.

Overall, less than 6% of staff have travelled to Wuhan, transited through Wuhan or had contact with people coming from Wuhan. No employee has been diagnosed with the infection.

We are closely monitoring the health of every employee. We have a sufficient number of staff to resume operations after the holiday break.

WuXi Biologics is also working carefully to ensure the quality of the products we are manufacturing is not affected by this outbreak. They have a strong GMP quality system and a robust global supply chain and not expect to see any negative impact of this outbreak on our operations.

Clients who plan to travel to China are suggested to conduct meetings via videoconferences or teleconferences. In addition, WuXi Biologics has already mobilized a large team in order to develop and manufacture multiple neutralizing antibodies to potentially treat the infection.

WuXi Vaccines, an additional of WuXi Biologics dedicated to vaccines, is also in discussion on the manufacturing of multiple novel vaccines. https://www.wuxibiologics.com/wuxi-biologics-provides-operation-update-related-coronavirus-outbreak/

The Best compilation of all job options in Pharmaceutical and CRO industries: Must read for freshers.

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The Best compilation of all job options in Pharmaceutical and CRO industries: Must read for freshers.

After graduation and post-graduation in life science(Bachelor in Pharmacy, Master in science or Pharmacy etc), students often find difficult to choose career/job options. I too felt the same so I decided to help all who are willing to work in Pharma and CRO industries. That is why this initiative of LifeProNow was started.

I worked for a decade in Pharma and CRO industry that too in different profiles, that has given me lots of understanding about various roles. (CRO-contract research organisation which works for Core Pharmaceutical companies based on agreement)

The question “which job options to be chosen” comes after “how many career/job options are available in Pharma and CRO industries.

So I will answer the first question first. Let’s learn them one by one. I will keep them very simple so that you do not get panic with the overflow of information. Purpose of this blog is to give an overview so I am not going into depth of each profile.

Clinical Data Management:

As a clinical data manager or Clinical data associate, you have to read the protocol, design the database and need to make sure that protocol related information (clinical data) are captured and it meets the desired quality standard before handing over to Statistician.

Clinical data manager plays a key role from inception of a clinical trial to its end. Any life science graduate or postgraduate can apply for this. 

Many institutes are conducting many courses, offline and online. If you have a degree in Pharmaceutical sciences, then courses are not a mandatory requirement, but if you do, it can give a good idea about job profiles and those institutes can guide you in finding a job as well.

In India, CDM courses cost around 20 to 30 thousands INR. 

Clinical research associate

Sometimes it is called a trial monitor or simply CRA. CRA visit the site (say Hospital where the clinical trial is conducted) to check the site activities, Clinical trial protocol compliance and any other site related issues. You need to travel a lot in this profile.

No particular course is needed.

Clinical Research Coordinator

In layman term, Clinical research coordinator assists the Principal investigator (PI)  in many site activities especially entering the clinical trial data into the database. 

They also respond to CRA (Clinical Research Associate)  and Data Manger’s queries. 
No Course is needed. You need to work on sites (hospitals).

Medical coding

Medical coders translate the Disease, adverse event and procedure to standard code based on Reference Medical dictionary. Clinical research industries and insurance companies both require the Medical coders.

No courses required

Pharmacovigilance

It is a well-known field now. It is also called Post-marketing surveillance or simply PV. There are many different kinds of profiles in this area. Profiles can be categorized into two fields: ICSR writing-related and Aggregate report writing.

Individual Case Safety Report (ICSR) Job Profile: PV associate has to evaluate and enter certain details e.g Age, Sex and Adverse event, Dose and time etc into a database for safety reporting.

Aggregate report writing Job Profile:  As the name indicates, it is a compilation of adverse event in a certain period of time. Most commonly it is PSUR (periodic safety update report). PSUR is also known as Periodic Benefit-Risk Evaluation Report (PBRER) in a few places.

Development Safety Update Report (DSUR): It is another aggregate report in which PV associate has to compile all the safety cases in a certain period of time, in an ongoing clinical trial.

Sometimes Aggregate report writing job profiles are classified under regulatory writing (Medical writing)

There are many other report writings which are country-specific.

Many institutes are conducting courses for PV. But diploma in PV is not an essential qualification for application in PV profiles but as I said earlier, you can develop a better understanding with less effort and those institutes can guide you for the job hunt. The average cost of these course in India is 20 to 40 thousands. 3 month to 1-year course programs in PV are available in Market.

Clinical Record Management

It is also called eTMF management or simply record management.

Record manager reviews the documents for its completeness, index them and save in assigned destination. 

Trial master files (TMF) is nothing but a collection of documents which are needed from a regulatory point of view. Nowadays, all documents are electronically saved by using different tools and software, that is why it is called an electronic trial master file or eTMF.

No Course is needed for this job profile.

Centralised monitoring:

Centralized monitoring associate has to monitor site performance, take appropriate action and provide recommendations about timely corrective action. It is also called risk-based monitoring.

For example, monitoring those sites or hospital which has a number of protocol violations

In this profile, you have to monitor various site activities based on centralised monitoring plan by sitting in an office. It is kind of remote monitoring of site (you can read about CRA for difference) based on certain key indicators. You can call it home-based CRA job. 

No course is required. 

Medical Writing

 The medical writer prepares the documents which are important for submission or any other communication with regulatory agencies. Generally, it is called regulatory medical writing

It is important to mention that companies can mention medical writer as job title but job details may mention aggregate report writing (PSUR, DSUR etc). So be careful while searching for the job and use both the keywords.

Scientific writing

Though some organisations are not very clear in using Medical writing and scientific writing job title. But in general, Scientific writing is non-regulatory writing;  for example writing an abstract, content of the website, press release, presentation any medical communication etc.

There are many online courses available for medical writing and scientific writing. Though having a diploma/ certificate in Medical or scientific writing is not an essential requirement but as I said earlier that Institute can guide you in many ways especially if you did not get proper exposure in academic life.

Regulatory affairs

As a regulatory affairs specialist, you create documents which are important for submission. It is sometimes called as regulatory medical writing. Regulatory affairs professionals should have a good understanding of laws and regulations about the drug submission process in various countries. Generally, there are many types of regulatory affair profiles. 

Regulatory (API), Regulatory (formulation)
Regulatory (For EU Submission)
Regulatory (US, Japan submission)
Regulatory (labelling)
Regulatory (IND, ANDA, sNDA)
Regulatory (biosimilars)
Chemistry, Manufacturing, and Controls regulatory

Offline and online courses are available for this. It may cost you around 20-30 thousand INR

Job as a packaging specialist

As we know, drugs are dispensed in strips, vials, injections, or any other packaging. So every Pharmaceutical companies require Individuals who know this stuff. You need to have the desired qualification in packaging technology or chemical technology. In India, IIP (Indian Institute of packaging) offers courses in this area.

Lab data analyst, clinical scientific expert and Medical Surveillance

These profiles are almost the same with little variation. As a lab data analyst or medical surveillance specialist, you will review the laboratory data (clinical data) and identify the signals

Signals are any trend of ups and downs in-lab data, for example, A consistent drop in haemoglobin etc. additionally you may be involved in the setup of reference ranges and units.

As a Clinical scientific expert, you will do the same thing, but you may also review the clinical study reports or other documents. These profiles are not globally available.

HEOR (health economics and outcome research).

Many therapeutic options/intervention are available in each category. The cost and benefit of these options vary a lot. Many Insurance and government authorities need a best and cheapest therapeutic option for the public. HEOR specialist does the systematic review (literature survey) to find the best available option for any ailment.

Medical Communication and Medical Information Manager:

These profiles are mainly Organisation specific and job role can vary from one company to another but largely they review the documents, perform a literature survey, coordinate with other departments and respond to queries related to any company’s product

Patent analyst job

As a patent analyst; you need to search for literature and databases for every minute details of the product-related patent. 

You may get an opportunity to work in patent application drafting.

You can do online free certification course for this.

Clinical Operation:

As a trial operation specialist, you will have budget management Responsibility, check for Sites readiness for initiation and Set up and maintenance of CTMS (clinical trial management system). Tracking of CRA visits to the site, and checks the TMF file completion. Coordinate various activities with vendor and sites.

They are responsible for the logistical aspects of a clinical trial.

Teaching

A well-known profession. I am not detailing it much.

Research and development:

You can go to analytical research, formulation development, chemistry lab, Pharmacology lab etc. I think all readers know this quite well. But You should make sure one thing that you need to go to higher education like PhD if you want to grow in this field

Production and QC

You can work in a tablet, Capsule, Injection etc production department. QA-QC department is also associated with this.

No Extra course is required.

Government Jobs

Pharmacist, Many govt labs, teaching staff, lab in-charge, scientist (PhD preferred) and Drug inspector are the areas which can be explored.

One thing I want to mention here that there are many governments plus WHO funded projects in India and Africa which requires Post graduates in life sciences for various roles. Please keep a watch on that (such as zonal Manager for Malnutrition study). Generally, these jobs will be on a contract basis.

SAS programmers

SAS is the most commonly used software across the industries. There are different kinds of programming jobs in the Pharmaceutical and CRO industries.

SDTM (standard data tabulation model) programmer: The regulatory authority needs clinical data in a certain standard format and these data sets are prepared by SAS programmer.

ADAM (Analysis data model) or statistical programmer: ADAMs are another kind of data-sets which should be submitted to the FDA. This helps in Statistical analysis.

Clinical programmer: There are many reports which are required for clinical data review or checking for any incorrectness or discrepancy;  for example, concomitant medication or adverse event reports. These reports are programmed so that data can be pulled from the database in the desired format. The clinical programmer does this work.

Database developer: Programmers are needed to build up the database especially the eDC.

eDC stands for electronic data capture and it is a crucial part in clinical trials as all data need to be captured electronically in the database (it is called CRF-case report form).

You have to do a certification course in SAS. It takes 3 to 6 months and cost you around 30-40 thousand INR.

Data Scientist

Automation, artificial intelligence, machine learning and big flow of data has given birth of data science domain. A data scientist in the Pharmaceutical industry gives insight about any improvement of a process or any new way of doing things or any conclusion based on given data.

You need to learn Python, R or SAS or any other programming language. You consider doing courses in Data Science as this is quite technical and requires practice and good programming skills.

Python and R are free languages and can be learned online through YouTube tutorial. Data science course may cost you around 30-50 thousand and may take 3 months to 1 year in general.

Sales Representative and Product Management

Medical representative or sales executive or representative has to describe the associated company’s products information to Doctors. Zonal management or Area management or Product Management are the different job profiles that you can get based on your qualification or experience. Pharma MBA degree from a prestigious institute can help you in getting a good start.

Market research

 I am not giving any particular definition for this but you can understand by reading about below job profiles:

Competitive Intelligence:  

The core work of this profile is to get the information about the company’s competitors and its work.

Suppose a company wants to develop a drug for asthma, then company requires to gather information about other companies drugs for asthma, their development status, mechanism of action, success/failure story, side effects, market share etc. 

Generally, the job title is a “Market Research Analyst”. There is no specific course for this and it is not required. You can get sufficient knowledge on google. You can follow the News section of this website and 50 percents work is done.

Please remember that with this title (Market Research analyst) there are many different kinds of job profiles.

You may work in database-developing companies like Global Data, Thomson Reuters. In this Database development-related profiles you need to gather information about Pharmaceutical companies and their products and update this information in the database. They use the database to generate particular reports.

You may work in profiles which involves the calculation of compensation for a sales representative. Say, there are 1000 sales representatives in any organisation, and you need to calculate compensation for them based on sales in a particular area.

Forecasting:

 This is another area whereas an associate or analyst (title) you forecast the sales of any drug, medical devices or biologics in any particular territory. You forecast the Market size/sale volume etc for the sale of the company’s products.

Pricing analyst:

As the name indicates, as a pricing analyst you help the organization to decide the price of their products in particular territory.

No course required.

Note down all the job profiles names which I mentioned above and make a list of your own. I strongly suggest that you go and search in google about all job profiles and read and read.

There are various roles within a role. For example, there is a Qc team in PV, the clinical team in CDM etc, Validate team in SAS etc but I covered 90 percents of Job profiles so You do not need to worry about this.

You can also read below blogs:

How to Search and get the job in Pharma and CRO industry-Part I –

Complete Guide for writing effective Pharma- Resume: Your First Impression

Best Use of Naukari.com for Pharma Jobs

FDA Continues tough Support of Innovation in the Development of Gene Therapy Products

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FDA Continues tough Support of Innovation in the Development of Gene Therapy Products

Jan 28, 2020: This is a pivotal time in the field of the gene therapy as the FDA continues its efforts in order to support innovators developing new medical products for Americans and others around the world. Up till now, the FDA has approved four gene therapy products, which insert new genetic material into the patient’s cells.

The agency think likely for many more approvals in the coming years, as evidenced by the more than 900 investigational new drug (IND) applications for ongoing clinical studies in this area, this will provide patients and providers with increased therapeutic choices.

In that spirit, today, the FDA is announcing the release of the number of important policies: six final guidances on the gene therapy manufacturing and clinical development of products and a draft guidance, Interpreting Sameness of the Gene Therapy Products Under the Orphan Drug Regulations

.One of the most important steps the FDA can take to support safe innovation in this field is to create policies that can provide product developers with the meaningful guidance to answer critical questions as they research and design their gene therapy products.

Overall, these policy documents are representative of the efforts to help advance product development in the field of gene therapy.

The FDA is an agency inside the U.S. Department of Health and Human Services which protects the public health by assuring the safety, efficiency, and security of the human and veterinary drugs, vaccines and other biological products for human use, and medical devices.

The agency also is responsible for the safety and protection of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. https://www.fda.gov/news-events/press-announcements/fda-continues-strong-support-innovation-development-gene-therapy-products

Clozaril, Fazaclo ODT, Versacloz (clozapine): Drug Safety Communication – FDA reinforce Warning That Untreated Constipation Can Lead to Serious Bowel Problems

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Clozaril, Fazaclo ODT, Versacloz (clozapine): Drug Safety Communication – FDA reinforce Warning That Untreated Constipation Can Lead to Serious Bowel Problems

Jan 28,2020: FDA is underpinning an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can, unusually, progress to serious bowel complications. This can lead to hospitalization or even death if the constipation is not diagnosed and treated quickly.

Background: Clozapine affects how the intestines (bowels) function in the widely held patients. It produces effects ranging from constipation (trouble having a bowel movement), which is a frequent incident, to serious but unusual bowel problems, including complete blockage of the bowel.

Recommendation: Patients should contact to their health care professional if:

  • Their bowel movements are not as much than normal.
  • Not have a bowel movement for at least three times a week.
  • Have hard or dry stools.
  • Have difficulty passing gas.
  • Patients should contact your health care professional immediately if you have symptoms which can be associated with the serious bowel problems such as: nausea, vomiting, bloating or belly swelling, or belly pain.

Health care professionals should:

  • Evaluate the bowel function before starting the patient on clozapine.
  • Avoid co-prescribing clozapine with other anticholinergic medicines (cause gastrointestinal hypomotility).
  • Advise patients frequently of the significant risk of the constipation and life-threatening bowel issues and the need in order to stay hydrated to prevent constipation.
  • Question patients concerning the frequency and quality of their bowel movements throughout treatment.

Healthcare professionals and patients are encouraged to account adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. https://fda.einnews.com/pr_news/508279977/clozaril-fazaclo-odt-versacloz-clozapine-drug-safety-communication-fda-strengthens-warning-that-untreated-constipation-can-lead-to-serious

Phase II DESTINY-Gastric01 trial of Enhertu (trastuzumab deruxtecan) versus chemotherapy met primary endpoint

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Phase II DESTINY-Gastric01 trial of Enhertu (trastuzumab deruxtecan) versus chemotherapy met primary endpoint

Jan 27, 2020: High-level results from the positive registrational Phase II trial DESTINY-Gastric01 showed AstraZeneca’s and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan), achieved a statistically considerable and clinically meaningful development in objective response rate (ORR) and overall survival (OS) in patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction cancer that had developed following two or more treatment regimens including trastuzumab and chemotherapy.

The trial met its primary endpoint of an improvement in ORR, as measured by an independent review committee, in patients treated with Enhertu compared to the investigator’s choice of the chemotherapy (irinotecan or paclitaxel monotherapy). 

Enhertu showed a statistically important and clinically meaningful improvement in OS, a key secondary endpoint.

Adverse effect: In general, safety and tolerability profile of Enhertu in DESTINY-Gastric01 was reliable with that seen in the published Phase I trial in which the most common adverse actions (≥30 percent, any grade) were haematologic and gastrointestinal that includes neutrophil count decrease, anaemia, nausea and decreased appetite.

Also, there were cases of treatment-related interstitial lung disease (ILD) and pneumonitis, the popular of which were Grade 1 and 2 with two Grade 3 and one Grade 4. No ILD-related deaths (Grade 5) occurred in the gastric patients in the Phase I trial or in the DESTINY-Gastric01 trial.Data from DESTINY-Gastric01 will be presented at a upcoming medical meeting.

In addition to the planned discussion with the Japan Ministry of Health, Labour and Welfare (MHLW), both companies plan to discuss their data with other health authorities. 

Recently Enhertu  received Accelerated Approval in the US for HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based treatment regimens and the additional global regulatory submissions in HER2-positive metastatic breast cancer are underway.

Enhertu is being jointly developed and commercialised worldwide with AstraZeneca except in the Japan where Daiichi Sankyo maintains exclusive rights.

DESTINY-Gastric01: DESTINY-Gastric01 is the registrational Phase II, open-label, multi-centre trial assessing the safety and effectiveness of Enhertu in 189 patients from Japan and South Korea with HER2-expressing advanced gastric cancer or gastroesophageal junction adenocarcinoma (defined as IHC3+ or IHC2+/ISH+) who have progressed on two or more prior treatment regimens that  includes fluoropyrimidine (5-FU) and platinum chemotherapy and trastuzumab.

https://www.astrazeneca.com/media-centre/press-releases/2020/phase-ii-destiny-gastric01-trial-of-enhertu-versus-chemotherapy-met-primary-endpoint-27012020.html

AstraZeneca’s Brilinta met primary endpoint in Phase III THALES trial in stroke

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AstraZeneca’s Brilinta met primary endpoint in Phase III THALES trial in stroke

Jan 27, 2020: High-level results from the Phase III THALES trial showed AstraZeneca’s Brilinta (ticagrelor) 90 mg used daily two times a day and taken with aspirin for 30 days, reached a statistically considerable and clinically meaningful reduction in the risk of the primary composite endpoint of the stroke and death, compared to aspirin alone.

THALES was conducted in more than 11,000 patients who had a minor acute ischaemic stroke or high-risk transient ischaemic attack (TIA) in the 24 hours prior to treatment initiation.

The initial safety findings in the THALES trial were reliable with the known profile of Brilinta, with an increased bleeding rate in the treatment arm.

The full THALES trial results will be presented at the forthcoming medical meeting.

Brilinta is approved in over 110 countries for the treatment of acute coronary syndrome (ACS) and in over 70 countries for the secondary prevention of cardiovascular (CV) events among high-risk patients who have experienced a heart attack.

Stroke: Stroke is the second main cause of death worldwide, with 6.2 million stroke-related deaths in 2017, from which 2.7 million were due to ischaemic stroke.

Patients who experience an acute ischaemic stroke or TIA are at high risk of the developing subsequent ischaemic events, with predominantly high risk within 30 days after the initial event and highest risk period being the first 24 hours after the initial event.

THALES:THALES is an AstraZeneca-sponsored, randomised, placebo-controlled, double-blinded, international, multicentre, event-driven trial involving more than 11,000 patients in order to test the hypothesis whether Brilinta and aspirin is superior to aspirin alone in preventing  composite of the  stroke and death in patients with minor acute ischaemic stroke or high-risk TIA. https://www.astrazeneca.com/media-centre/press-releases/2020/brilinta-met-primary-endpoint-in-phase-iii-thales-trial-in-stroke-27012020.html

FDA accepts for priority review Sanofi’s Dupixent® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis

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FDA accepts for priority review Sanofi’s Dupixent® (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis

Jan 28, 2020: The U.S.FDA has accepted Priority Review the supplemental Biologics License Application (sBLA) for Sanofi’s Dupixent® (dupilumab) as an add-on maintenance treatment for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not effectively controlled with topical prescription therapies or when those therapies are not advisable, target action date for the FDA decision is May 26, 2020.

Regardless of standard-of-care therapy, many young children suffering with moderate-to-severe atopic dermatitis continue to experience uncontrolled, persistent symptoms.

These children live with intense, persistent itching, skin lesions along with skin dryness, cracking, redness or darkness, crusting and oozing.

The sBLA is supported by the data that includes pivotal Phase 3 results on the efficiency and safety of Dupixent shared with topical corticosteroids (TCS) in children with severe atopic dermatitis.

Results of the trial shows, children treated with Dupixent and TCS experienced considerably improved measures of overall disease severity, skin clearing, itching and health-related quality of life, compared to TCS alone. 

Adverse events more commonly observed with Dupixent included conjunctivitis, nasopharyngitis and injection site reactions, which is consistent with the previously documented safety profile of Dupixent in older populations. 

In 2016, the FDA granted Breakthrough Therapy designation to review Dupixent for the treatment of severe atopic dermatitis in the childrens of 6 months to 11 years of age not well controlled on topical prescription medications.

MOA: Dupixent is a fully human monoclonal antibody that inhibits signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins.

Data from the Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a key role in atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP).

https://fda.einnews.com/pr_news/508230379/sanofi-fda-accepts-for-priority-review-dupixent-dupilumab-for-children-aged-6-to-11-years-with-moderate-to-severe-atopic-dermatitis

AstraZeneca divests rights to Inderal, Tenormin, Tenoretic, Zestril and Zestoretic to Atnahs Pharma (Atnahs) to established hypertension medicines

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AstraZeneca divests rights to Inderal, Tenormin, Tenoretic, Zestril and Zestoretic to Atnahs Pharma (Atnahs) to established hypertension medicines

Jan 27, 2020: AstraZeneca has decided to sell the global commercial rights to Inderal (propranolol), Tenormin (atenolol), Tenoretic (atenolol, chlorthalidone fixed-dose combination), Zestril (lisinopril) and Zestoretic (lisinopril, hydrochlorothiazide fixed-dose combination) to Atnahs Pharma (Atnahs).

The agreement excludes the rights in the US and India, which were previously deprived, and in Japan, which will be reserved by AstraZeneca.

These medicines, used primarily to treat hypertension, have lost their patent protection worldwide. AstraZeneca will continue to manufacture and supply to Atnahs during a transition period.

Financial considerations: Atnahs will make an candid payment of $350m to AstraZeneca. AstraZeneca may also be received future sales-contingent payments of up to $40m between 2020 and 2022.

In 2018, Inderal, Tenormin, Tenoretic, Zestril and Zestoretic produced annual sales of $132m in the markets covered by this agreement. 

The divestment is expected to be completed in the first quarter of 2020, subject to customary closing conditions and regulatory clearances.                                                                     

https://www.astrazeneca.com/media-centre/press-releases/2020/astrazeneca-divests-rights-to-established-hypertension-medicines-27012020.html

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