When selecting a pharmacovigilance (PV) partner to assist in case processing, signal detection, aggregate reporting, and medical monitoring needs, the team who will ultimately be working with you is often not present at the bid meeting. You may have a chance to see organizational charts or even CVs, but it may be hard to determine from relevant experience based solely on these reports.
As a senior safety physician for UBC, I’m actively engaged in all of these activities for our clients, and I strongly believe that your safety physician (or medical reviewer) truly matters. It’s important to consider the expertise of your entire PV team, especially your safety physician, when selecting a PV partner.
For most pharmaceutical companies, hiring a PV team will help alleviate some of the work of the existing internal team performing PV activities. Although your company may have internal medical directors, and they may even be involved in reviewing cases, a good safety physician can help the PV team to seamlessly fit with your existing team. A good safety physician can be a leader—a bridge who “speaks the same language” as your medical director but is also part of the day-to-day team reviewing cases as part of a case processing team, unlike a team manager who may just have oversight of case workflow.
A good safety physician has the medical and PV background to know and understand what information needs to go into ICSRs and the impact on the overall safety review of your product. What goes into your ICSRs affects not only the individual report but is also important for signal detection and aggregate reporting. Quality coding helps for retrieval of events, proper analysis makes the work of aggregate reports and signal detection easier. The physician needs to be able to add queries to the case and know the differences and what to expect from clinical trials versus post-marketing reports. Once again, a good safety physician may act as a bridge between clinical, case processing, safety writing, and signal detection teams (whether these activities are kept in-house or outsourced to your PV partner).
I take pride in my role as a senior safety physician and I’m thankful for my interactions with both the UBC and client teams. I am able to positively contribute by educating and working with my internal UBC team, as well as being integrated into the client team, working together to make meaningful and valuable contributions to understanding the safety profile of medicinal products.
ABOUT UBC:
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. Our combined scientific expertise in pharmacovigilance, risk management, and signal detection and assessment, underpinned by innovative technologies, offer our customers customized solutions generating the relevant insights necessary to make informed decisions earlier, meet stakeholder requirements, and ensure the safety of products.
ABOUT THE AUTHOR:
Ashleigh van Dijk, MD
Senior Project Physician, Pharmacovigilance
Dr. Ashleigh van Dijk, MD, is an American doctor and Senior Project Physician at UBC, working remotely from Paris, France. Dr. van Dijk has been part of the PV Global Safety Writing & Medical Safety team for over eight years, overseeing clients both in the clinical development and post-market settings in many therapeutic areas including Critical care, Hematology and Oncology, Rare diseases, Hepatic diseases, Infectious diseases, Transplant medicine, Dermatology, Ophthalmology, and Women’s health. Dr. van Dijk’s activities as a Senior Project Physician include medical monitoring in clinical trials, medical review of Individual Case Safety Reports (ICSR), signal detection and signal management, and medical review of periodic reports. Dr. van Dijk’s leadership, collaboration, medical knowledge, and attention to detail are recognized by UBC’s clients in contributing to successful PV partnerships.
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