Director, Pharmacovigilance

Director of Pharmacovigilance   Position Summary: The Director of Pharmacovigilance (PV) will provide strategic and operational support for the Company’s global pharmacovigilance and drug safety activities. This individual will contribute to the timely detection, evaluation, reporting, and communication of safety information in compliance with global regulatory requirements while supporting the development of innovative therapies from early clinical development through commercialization planning. In this highly collaborative role, the Director will work closely with the VP Clinical Safety, Clinical Development, Clinical Operations, Medical Monitoring, Regulatory Affairs, Data Management, Biostatistics, Quality Assurance, and external pharmacovigilance vendors to maintain a high-quality safety program that supports patient safety and regulatory compliance.   Key Responsibilities: Safety Operations Oversee day-to-day pharmacovigilance activities performed internally and by external safety vendors. Ensure timely review, assessment, processing, tracking, medical evaluation, and regulatory reporting of adverse events, serious adverse events, SUSARs, and other safety information.Monitor vendor performance through KPIs, quality metrics, and governance meetings. Ensure inspection readiness and compliance with global pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP). Signal Detection & Risk Management Contribute to ongoing safety surveillance and signal detection activities. Participate in benefit-risk assessments throughout clinical development. Participate in establishing risk management strategies and safety governance. Present emerging safety issues and recommendations at cross-functional team meetings. Medical Review & Regulatory Support Collaborate with Clinical Development and Medical Monitors on medical review of safety events. Lead preparation and review of aggregate safety reports, including: Development Safety Update Reports (DSURs) Annual safety reports Safety sections of Investigator’s Brochures Clinical Study Reports Regulatory responses related to safety Support preparation of INDs, CTAs, BLAs/NDAs, RFIs and other regulatory submissions. Cross-Functional Collaboration Partner closely with Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, Quality Assurance, and CMC teams to ensure appropriate safety oversight. Support Data Monitoring Committees and Safety Review Committees as needed. Contribute to protocol development, informed consent documents, and safety monitoring plans. Quality & Compliance Develop and maintain pharmacovigilance SOPs, work instructions, and quality documentation. Support audits and regulatory inspections. Drive continuous process improvement across pharmacovigilance activities. Ensure compliance with FDA, EMA, TGA, PMDA, ICH, and other applicable global regulations.   Qualifications: Education MD, NP, PharmD, PhD, or equivalent advanced life s...