CSRM Physician - Senior Principal Scientist, Drug Safety

Role: The CSRM Physician leads pharmacovigilance activities, overseeing clinical risk management and safety surveillance for assigned investigational and marketed products. Responsibilities include chairing the Risk Management Safety Team (RMST), developing and maintaining risk management/ pharmacovigilance plans, evaluating safety data from trials, literature, and post-market use, and ensuring safety information accuracy in regulatory documents. The role involves close collaboration with clinical development, regulatory, epidemiology, and manufacturing teams, with a focus on safety data analysis, signal detection, and risk minimization strategies. The physician provides scientific input for safety-related regulatory submissions, such as CSRs, RMPs, and labeling, and supervises safety data review activities. Qualifications include an MD or DO with at least 3 years of post-graduate clinical experience, prior drug development or pharmacovigilance experience, and strong communication and analytical skills. Preferred qualifications include board certification. High-value biopharma specifics encompass experience with safety surveillance, risk management, and regulatory documentation, primarily for pharmaceutical products in clinical development or post-approval, with expertise in MedDRA. The role involves cross-functional collaboration and is based in a hybrid work setting, with no travel specified.