What is Pharmacovigilance?
By: Barton Cobert MD, FACP, FACG
So you’re considering a career in pharmacovigilance and drug safety? What exactly is it? It is a combination of medicine, Sherlock Holmes detective work, writing, analysis, judging the safety and efficacy balance of drugs and public health. It is, in a nutshell, a passionate career for a health care professional.
It involves the collection of adverse events (old term: side effects) of drugs and devices, putting them into a well constructed medical summary case report, hunting down the full dataset (co-medications, past medical history etc.), getting them into a database, doing a thoughtful medical analysis to try to determine whether the “bad things” were due to the drug, the underlying disease or some other factors. These reports must then be sent to the FDA and their counterparts abroad. In addition, to analyzing adverse reports on individual patients, companies and governments put together “aggregate reports” which are summaries of all the safety issues seen with a drug over the last year (or more frequently for newer drugs) and coming to a conclusion as to whether the labeling should be changed (e.g. new contraindications, warnings, precautions, dose change, restrictions on use etc.) and sometimes even whether the drug should remain on the market! There is a similar process done for drugs that are in clinical trials and not yet on the market.
Pharmacovigilance is a combination of art and science dealing with cold facts but also suppositions, incomplete data and, yes, occasional misinformation and even lies (“no I certainly didn’t have wine with my medication.”).
Much of the drug safety work is steady and calm…but every now and then a crisis occurs where action is needed within minutes or hours: 3 babies had seizures in Kansas after using a cough/cold preparation; there is a report of tampering in LA; two patients just had a Stevens Johnson reaction in a clinical trial. These are exciting times: the FDA jumps, the company jumps and the blogosphere jumps! And you, the pharmacovigilance officer has to do the right thing right now!
Whom can you work for? Pharma and device companies obviously. But also the FDA (they’re actually hiring now!), NGOs (non-governmental organizations), Clinical Research Organizations (companies that do clinical trials for drug companies), consultancies (e.g. Deloitte) and sometimes hospitals and other medical organizations. There are also physicians and others who do PV consulting on their own as I do. There are medical information, education and writing jobs in PV: I’ve written several textbooks on drug safety and pharmacovigilance.
I’ve been doing this for 25 years and have had a ball! It is fascinating, exciting, always an interesting, unpredictable-never-a-dull-moment combination of science, “art”, people skills and public health. I’ve traveled the world, met incredible people and (I like to think) contributed a bit to public health and made a few dollars.
GO FOR IT!
Dr. Cobert is a Mentor at our upcoming SEAK Non-Clinical Careers Conference
Bart Cobert MD, FACP, FACG, BLCMD Associates, LLC (Westfield, NJ)
Barton Lewis Cobert, MD, FACP, FACG, FFPM has had a long, distinguished career in pharmacovigilance, drug safety and risk management. He was senior director pharmacovigilance for Schering-Plough Research Institute and held similar positions for Novartis Consumer Health Inc. and Medidata Solutions. He has represented his company and Pharma at many international meetings and organizations including the International Conference on Harmonization (ICH). Dr. Cobert received his BA from New York University and his MD from New York University School of Medicine. He is board certified in Internal Medicine and Gastroenterology. He has written and lectured extensively both nationally and internationally on pharmacovigilance. He has written three books on drug safety including the Manual of Drug Safety and Pharmacovigilance which is used as a textbook in courses on drug safety. Dr. Cobert is president of BLCMD Associated LLC, a drug safety and pharmacovigilance consulting company in Westfield, NJ.