“What is it you do at Prevail, and how much experience do you have at it?
I am the Associate Director of Pharmacovigilance (PhV) with 20 years’ experience. I am responsible for managing the activities and resources for the PhV group at Prevail, which include coordinating project/database setup, tracking project budgets, managing the PhV teams, and ensuring compliance for SAEs and SUSARs worldwide. I also provide ad hoc guidance on clinical safety and regulatory authority reporting issues to company personnel and sponsors. Authorizing and maintaining PhV-related company SOPs and coordinating database setup are some of my higher-level tasks.
“What challenges to companies most often face when it comes to Pharmacovigilance?”
A big one is inadequate system technology that inexperienced sponsors get that go over budget. Also, when there’s crossover between PhV and another area, a lack of understanding leads to mistakes that bring up study budgets and elongate study timelines.
“How do you and the rest of the Prevail team help solve those challenges?
The Prevail PhV team and I do 3 main things to tackle this. We provide guidance to sponsors, internal disciplines, and related or parallel disciplines. We assist Prevail’s engineers in system enhancement planning by providing subject matter expert/industry standard input. We also have identified safety-related activities that should be included in every sponsor budget and have collaborated with Prevail’s Business Development team to create the most accurate and reliable budgets possible.
