25 Years of Pharmacovigilance Experience
Elenie Bartzokis is an internist who practiced in a group practice setting for about 6-7years. She loved practice, seeing patients and having that interaction.
She practiced in the early ‘90s when HMOs were starting to take more control over physician practice and she started to feel that she wasn’t as happy with the way she had to practice. It was not what she went into medicine to do.
Her former Chief Resident called her and said she was looking for physicians to join her in the pharmaceutical industry. Lenie’s response was “I’m not going to be a drug rep”. She felt she couldn’t leave practice, she’d put so much into her training. The colleague reminded Lenie that she would always be a doctor, no one could take that away from her. She proposed that Lenie consider consulting to evaluate the pharma role and learn more.
After a few more frustrating issues that occurred related to patients and her ability to lead their care plans versus it being dictated by an HMO, she decided to give pharma a try and …
“I have not looked back since”.
Related to leaving practice, Lenie’s experience is that you could go back to clinical practice within 2-3 years – much more than that she believes would be difficult. In fact, she only knows one physician in her 25 years of pharma experience that went back to clinical practice.
She found the pharma industry “intellectually fascinating” – having not been exposed to what goes into making and marketing a drug during training she really enjoyed learning this in pharma.
What is Pharmacovigilance (PV or PVG)?
Lenie started in 1995 and relays that the function has changed dramatically over the years. When she started, in “big pharma”, there were not many physicians involved in PVG. The role included writing a report on the safety or adverse event and submitting to the FDA. She also did the actual data entry into a safety database. Regarding data entry, she is grateful for that experience that many physicians might consider beneath them (and this was at the time that EMR was not in existence! patient charting was paper charts and dictaphones).
She learned important skills and knowledge that allowed her to grow and ultimately build PVG groups from the ground up given she understood PVG from “alpha to omega”.
Transitioning from FTE (full-time employee) to Consulting:
Her transition occurred about 10 years into her career; family issues led to the need to leave her FTE role. She was actively caring for her dying father and the company was in the midst of a critical regulatory submission (NDA = new drug application). Although she loved her VP role in this small biotech company she realized she could not do both and felt leaving was the best for her and also the company.
After about six months, she was ready to go back to work and thought she would find a part-time role. A former colleague called asking if she did consulting work. And she said “yes!”. Lenie recalls that she did not think she would do consulting until she had ~20 years of pharma experience but this opportunity presented itself and she has been consulting for 15 years now.
Elenie describes Pharmacovigilance as the “closest thing to patient care that I can get – patient interaction was my favorite part of medicine”.
With PVG it is like you are evaluating a patient. Asking questions about a safety or adverse event, understanding what the evaluation included and documenting a clear clinical story such that you can best understand the drug that is being evaluated. “I’m one step away from being with the patient”.
An entry level PVG role is focused “really getting a handle on what the drug is doing from a safety perspective”
In this role you learn:
- how safety information comes into the pharma company
- what is a clinical trial; what are the phases of clinical research
- what you can or cannot ask the treating physician (post-marketed drug) or the Principal Investigator (drug being studied in clinical trial)
- understanding the regulatory definitions of “serious”
- determining “expectedness”
- coding using a coding dictionary
- data analysis and “signal detection”
PVG is usually specialty agnostic. You don’t need academic clinical research or publishing experience for these roles. The clinical practice experience and medical training is what is valuable for PVG. The regulations regarding patient safety are the same regardless of therapeutic area.
Lenie has worked in large pharma companies, mid-sized and even start-up biotech. Her advice to a physician newly entering pharma is not to go to a small company where there is no safety department; “you are set up for failure”. This is because you need PVG experience to be able to really know how drug safety is conducted within the realm of pharma. You need some on-the-job training to understand the regulatory aspects of PVG.
“Pharmacovigilance is 50% clinical/medical and 50% regulatory”
I asked about “Pharmacovigilance” vs. “Drug Safety” – is there a difference?
Every company has a different naming approach but typically PVG encompasses all safety – both safety for clinical trials and post-marketing. Sometimes the term “clinical drug safety” is used specific to clinical trials.
“It’s patient safety, not drug safety”
There are a lot of terms used in today’s blog – The links I’ve provided are a starting point. FDA and EMA (European Medicines Agency) websites are great resources to learn more about the regulatory aspects of pharmacovigilance. Be curious! Read and learn!
Here are a few others for your learning!