Pedro Gomes | Global Director, Pharmacovigilance (PV) Quality Assurance Lead
MSD

I am a Doctor of Pharmacy (PharmD) with a Master’s degree in Pharmaceutical Science and several years of experience in Pharmacovigilance (PV) Quality Assurance (QA). Over the course of my career, I have conducted more than 100 PV audits worldwide and participated in various PV and Good Clinical Practice (GCP) inspections conducted by regulatory authorities, including the FDA, EMA, MHRA, and TGA. Currently, I serve as the PV QA Lead at MSD, where I am responsible for managing global quality assurance activities in critical areas such as Safety and Pharmacovigilance, Regulatory Affairs, Real-World Evidence (RWE), and Medical and Non-Interventional Studies (NIS). Additionally, I actively contribute as a member of the RQA Pharmacovigilance Committee. Prior to my role in PV QA, I worked extensively in various aspects of PV operations, including e.g. case management, risk management, and signal management.