• Own end-to-end clinical trial pharmacovigilance activities for Sponsor studies; serve as the operational backbone of the safety function • Provide active Sponsor oversight of CRO pharmacovigilance activities, including compliance, quality, and performance metrics • Lead or contribute to DSURs, IND Annual Reports, safety narratives, and line listings • Aggregate, review, and analyze safety data across studies to identify trends and emerging safety signals • Prepare integrated safety summaries and materials for safety review meetings and signal detection discussions • Maintain continuous inspection readiness for FDA and global health authority inspections • Coordinate literature surveillance, collaborate with biostatistics, and support cross-functional safety evaluations • Liaise with Clinical Operations, Medical Affairs, Regulatory Affairs, Data Management, and CRO partners