CSRM Physician - Senior Principal Scientist, Drug Safety

Position Overview: The CSRM Physician leads clinical risk management and safety surveillance for assigned investigational and marketed products. Chairs the Risk Management Safety Team (RMST) and leads development/maintenance of risk management and pharmacovigilance plans. Primary Activities: Participate on Product Development Teams; chair the RMST and related sub-teams for assigned products. Partner with clinical development and Clinical Research to ensure safety-focused clinical programs and benefit-risk evaluations in aggregate safety reports. Coordinate with cross-functional teams (clinical development, epidemiology, regulatory affairs, statistics, manufacturing) to align safety activities with global PV/risk management strategies. Evaluate safety data from multiple sources (clinical trials, literature, post-approval use) and ensure completeness in CCDS. Provide scientific strategy for safety documents (CTD components, RMPs, Periodic Safety Update Reports) and ensure medical/scientific appropriateness of product circular safety sections. Lead safety surveillance (aggregate analysis, post-approval safety signaling reviews) using medical judgment; collaborate with CSRM Associate. Drive risk management actions: pharmacovigilance action recommendations, labeling recommendations, and development of RMPs, PV strategies, and risk minimization. Oversee review/approval of labeling files in the safety database; demonstrate MedDRA knowledge. Prepare safety summaries/analyses for regulatory filings; may supervise CSRM medical associates. Education: Required: MD, DO, or equivalent Preferred: Board Certification Required Experience & Skills: 3+ years clinical experience post-graduate training (or relevant clinical experience) Prior drug development experience (clinical and/or regulatory) Experience in clinical safety, pharmacovigilance and/or risk management Organizational leadership; excellent communication, writing, and analytics Required Skills: Clinical Risk Management, Clinical Safety, Data Analysis, Detail-Oriented, Drug Safety Surveillance, FDA Submissions, Patient Safety, Pharmacovigilance, Safety Reporting Preferred Skills: Oncology #J-18808-Ljbffr Scorpion Therapeutics