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The ideas, views and opinions expressed in here in blog or comments and profile represent my own views and not those of any of my current or previous employer .They are based and taken from regulatory guidance available freely and my interpretations from my experience.

Saturday, 29 June 2019

Pharmaceutical Career options for healthcare professionals



Job opportunities in Pharma!!!!!

Lot of healthcare professionals want to venture in the world of corporate pharmaceutical industry but yet, many remain skeptical and clueless.Reasons for it are many and one of the reasons is sometimes they have an idea from google or someone they know, but they want to know more from someone who can direct them in more detailed manner.Unfortunately this someone is not available easily with honest guidance. (*I have special reference to one of the institutes offering excellent courses in this domain at the the end of my blog,do check).

I came to know this situation, because I get approached by many MBBS/BDS/BAMS/B.Pharm  pass out students on how do they start their journey and what is career prospects in this domain? Most of the time, they approach me on facebook/linkedin/Quora where it is really difficult to summarize and guide them via chat.Hence this blog.

But before i open the topic, i would like to clarify that I am not an industry expert neither claim to have deep knowledge in this area.  I have decided to write my 2 cents of knowledge to help someone looking for a starting point to begin their career in pharmaceutical industry.

To start with, I have enlisted few of the different areas in Pharma industry where healthcare professionals are required along with the job titles as an example below. But this is neither exhaustive list nor it is bulletproof, it should be taken just as reference.

  1. Clinical operations
shutterstock


We do know that clinical research is the backbone of getting newer or lets say better drugs in the market. Conducting  clinical research is a long term process which involves multiple stakeholders including  physicians and other HCP (health care professionals). 

To run a clinical research project i.e. clinical study/trial, pharmaceutical companies need people who understand the patient and his/her medical status to understand the disease, the medicinal product being researched, how it will help the disease etc. Companies are looking for a healthcare professional with good understanding of clinical trials, inclusion/exclusion criteria to recruit patients, monitoring of the trials, writing clinical protocols, taking informed consent from patients, and to monitor the safety of patients during clinical trials and so on.
The Job titles that are most commonly referred are Medical Monitor, CRA, Clinical and Safety Associate/Manager/Head. As someone gradually progresses in career, usually  the preference is for MD.Pharmacology for the topmost position in department (at least in India).
 
www.nia.nih.gov
2. Pharmacovigilance (PV)
There is tons of information including definition of pharmacovigilance online, but instead of technical jargon, I am taking the approach of writing it in layman's language. So basically  PV is about collection and analysis of side effects or adverse events associated with drugs and then taking decision regarding the drug based on data collected to ensure drugs are safe for patients as treatments.
The job titles or roles available are pharmacovigilance expert/medical reviewer/safety physician/drug safety advisor/medical director/safety leader.
Although the job primarily starts with reviewing the side effects/adverse event reports of patients, it is much more beyond that, extending to the challenging and fulfilling role of being responsible for a drug for its safety and efficacy and taking decisions regarding its life cycle.


3. Medical Affairs
Medical affairs is the most important department which is central glue to all other departments mentioned herein, more so in Indian Pharma companies, where they play varied and crucial role in every domain. The primary role of medical affairs is to help pharma companies to write scientific literature,product information and to meet with the other practicing doctors to create awareness regarding the availability of  their better and effective drugs. Apart from the primary responsibilities mentioned herein, they help in other areas like clinical operations,pharmacovigilance,medical writing etc.
The medical affairs department job titles include Medical advisor/Medical head/brand leader/Medical affairs head,medicomarketing manager(not used much now) etc.

4. Clinical Data management

Well, we are in a world where information is the currency, but unless its converted into meaningful data, it cannot be used, right? Clinical data management forms the core of any pharma company especially those dealing with new products and where clinical data managers play varied roles and responsibilities. They help in collecting and maintaining patient data and all other associated data collected during the clinical trial and store it in secure database,code it,retrieve it, analyse it and so on.

Different titles in this domain are clinical data associate, clinical data analyst, clinical data manager , director etc.
www.indiamart.com

5.Regulatory affairs

The regulatory affairs department  is responsible for obtaining permissions and fulfilling requirement or requests from regulatory agencies/health ministries for company drugs. Different  activities that they perform are  obtaining approval for new drugs from health ministries (they are called as regulatory agency or health authority) and ensuring that permission is maintained for as long as the company wants to keep the product on the market.They also are responsible for different requests such as dossier preparation, maintenance of product information etc as per legal requirements led down by Health authorities.
The different titles available in this field are regulatory affairs associate, manager, director, specialist.

6.Medical writing

Medical writers are responsible for writing medical documents that present information clearly and concisely. This can be any documents such as marketing materials, drug information documents, clinical study protocols, pharmacovigilance reports,IB,clinical study report etc.

There are limited opportunities for MBBS per se, but if someone is passionate then of course,they can find a way.

There are other departments as well in pharma companies for jobs for HCPs, however on practical note, i have presented those that are most commonly known, and are easily accessible to apply for a job role.

Growth opportunities : I would like to finish the topic by putting my 2 cents about growth in this career. Remember that as for any other career same rule applies here too, growth depends on number of factors, your skill, attitude, hardwork and availability of opportunity at right time for you etc. 

Special tip for doctors: Doctors if you do decide to join this domain, you should do it because you actually like it. I have seen many doctors who are not prepared to follow 9 to 5 time routine, deal with documentation, not ready to accept the criticality of the work in absence of actual patient standing in front of them, not ready to learn soft skills needed in corporate sector, not ready to learn new computer skills, and  not ready to apply medicine knowledge in different corporate sector. Please know the differences in hospital and corporate job, and then take conscious decision of joining whichever field appeals to you.



Further reading and training : I will try to include more resources for reading, learning and institutes offering both in my next blog. 
As far the institutes, let me start in this blog post with special mention to RISETRAINING who are doing excellent job in providing courses for Pharmacovigilance, Medical Writing, Computer System Validation and Argus Administrators. They also provide Job Consultation and 100% placement guarantee. And the best part is they are Training Students both online and offline. Check out more details @ http://www.risetrainings.com/

I hope this has given bit more clarity and help to readers, and I wish you the best for your career, whatever field you choose. 

Thanks for reading,

Dr.shraddha Bhange.

Connect with me Via comments below.
Support the cause of better rural education with me:ThinkSharp Foundation http://thinksharpfoundation.org/#home
(Images are taken directly from Google).



Sunday, 23 June 2019

Pharmacovigilance and beyond~old blog with new content



After 3 years of a break, I am attempting to restart writing my blog which will cover pharmacovigilance topics, primarily, and whenever appropriate some other relevant topics.  I am deeply thankful to my old readers and followers who kept on contacting me to write the blog again. I am humbled by their response for my amateur attempt of writing. Although I am no expert in this field the reason of starting this can be summed in below 2 points:                                                                 
  • Learning by sharing knowledge: Pharmacovigilance (PV) is a vast domain which is tightly governed by rules, regulations, guidance’s, which are at times too many to follow and remember. In addition, in PV, the race is against time, to remember these rules/guidelines on time to be compliant with submission to Health Authority is not always possible. Sometimes you have luxury of time and you read, understand and apply this regulations/rules for yourself, but the same luxury is not available to one of your colleagues, who can benefit from your knowledge. With the same intention, I have restarted my blog, to learn together by sharing our knowledge. Particularly Pharmacovigilance knowledge (and other related domain) to be complaint to ensure patient safety!
  • Awareness regarding PV: The other aspect of writing this blog is to create awareness regarding pharmacovigilance and other domains of pharmaceutical industry that make medicines available to patients. A doctor without a treatment for your disease (i.e. drugs/medicines) is like a soldier without weapon in a war. Healthcare professionals working in pharmaceutical industry do work behind the scenes to make these drugs available to patient that are safe and effective.
The posts will be particularly short (I will try my best) and will talk about different interlinked topics such as career options in pharma industry, PV regulations, Regulatory guidelines, hypothetical case scenarios, various medical/clinical topics, diseases etc. But focus will be to cover PV topics.

Thanks for reading,

Dr.shraddha Bhange.

Connect with me Via comments below.
Support the cause of better rural education with me :ThinkSharp Foundation http://thinksharpfoundation.org/#home

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