Pharmacovigilance Manager

Seeking an experienced Safety Physician to provide medical oversight of drug safety and pharmacovigilance activities across clinical development programs. This individual will lead safety signal evaluation, support regulatory submissions, collaborate with cross functional teams, and ensure compliance with global pharmacovigilance requirements. Key Responsibilities Lead medical review and assessment of clinical safety data and safety signals. Support safety surveillance, risk management, and benefit-risk assessments. Contribute to aggregate safety reports (DSURs, PADERs, PBRERs). Review and provide safety input on clinical protocols, investigator brochures, informed consent forms, and Reference Safety Information. Partner with Clinical Development, Medical Monitors, and external pharmacovigilance vendors. Support regulatory responses, inspections, and audits. Contribute to SOPs and pharmacovigilance guidance documents. Qualifications MD with clinical practice experience. 5+ years of Drug Safety/Pharmacovigilance experience within biotech, pharmaceutical, CRO, or regulatory environments. Oncology/Hematology experience strongly preferred. Strong knowledge of US/EU pharmacovigilance regulations, ICH guidelines, and CIOMS. Experience with ICSR review, causality assessments, aggregate safety reporting, safety surveillance, and risk management. Prior experience supporting regulatory submissions and health authority interactions preferred. #J-18808-Ljbffr