Drug Safety and Pharmacovigilance Career – Do’s and Don’ts
It’s easy to get absorbed and lost in the expansive field of Pharmacovigilance. Few google searches and the internet has tonnes of articles, notes, material to offer. What helped me filter out all the information as a beginner in Drug Safety was to categorize them as –
DO’s and DON’TS.
DO’S
1 .BASICS AND GUIDELINES
Let’s start from the basics. Find out the guidelines from the regulatory bodies (FDA for United States, MHRA for UK, etc). Find out how with your background as a general physician, dentist, pharmaceutical scientist can contribute to the field. Learn what entails the Department of Drug Safety and its reach through different organisations, companies.
2. SKILLS
As a Drug Safety Associate one must know the language of Pharmacovigilance. Language here means – learning about the several databases : ARGUS, ArisG, PVH. Understanding the importance of work-flow states and timelines with each Individual Case Safety Reports (ICSRs). How to report an adverse event using- MedDRA (the Medical Dictionary for Regulatory Activities). Granted these skills are often acquired with time as one gains practical experience when working in an organisation; it’s good to be aware of all the skill sets required for your role.
3. A Drug Safety professionals as a MENTOR
Most of the terminologies and workings of the Pharmacovigilance Department are new even for General Physicians and other healthcare professionals. A mentor can guide you through the workings of the industry, can translate and filter the huge chunk of information and simplify the Drug Safety career path. It is essential for those starting out in this field to get a good sense of judgement, direction and constant guidance through a Mentor.
DON’Ts
1. RANDOM CERTIFICATIONS
With the surge of information on the internet, there’s also a surplus of arbitrary certifications. These certifications usually require less than a day of training and readily handover a sheet of paper. This has no practical usage in the real world of Pharmacovigilance as the career path of Drug Safety requires application based training which is time consuming (certainly can’t be finished over a few days). While it’s good to update your resume with such “certificates”, it’s authentic to take time, learn and get trained by certified professionals in Drug Safety.
2. TAKING ADVICE FROM NON – DRUG SAFETY PROFESSIONALS
At a glance the field of Pharmacovigilance may give the notion of something to do with Pharmacy. However, it could not be more far from the truth. Pharmacovigilance deals with the science and activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other drug related problem extending to – herbals, traditional and complementary medicines, blood products, medical devices, vaccines. Since the field is vast and contains many workflows within it – a Drug Safety Personnel is best equipped to answer all the how’s, what’s and why’s. A professional from any other related field, though unintentionally, might not have the best judgement to offer.
3. NOT APPLYING THE LEARNT KNOWLEDGE
The workings of the Drug Safety department is best learnt when applied. Learning the theory aspect of the safety databases, narrative writing, MedDRA is a good starting point but certainly not enough. Hands on training is also a skill to go for in order to understand them efficiently.
