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 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
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.
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.
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.
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.
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 (IND, ANDA, sNDA)
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.
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.
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.
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 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.
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.
I am not giving any particular definition for this but you can understand by reading about below job profiles:
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.
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.
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: