VP of Drug Safety/Pharmacovigilance

Role: Vice President of Pharmacovigilance leading patient safety, risk management, and compliance for an oncology-focused biopharma with a pipeline including late-stage assets preparing for BLA submission. Responsibilities: provide strategic guidance on safety evaluation, benefit-risk assessment, and global pharmacovigilance systems; oversee safety governance, collaborate cross-functionally with Clinical Development, Regulatory, Medical Affairs, and external vendors; lead safety signal detection, regulatory interactions, and updates to safety documentation; develop policies and manage vendor performance; ensure compliance with FDA, EMA, and other agencies; build and mentor the pharmacovigilance team. Requirements: MD or equivalent; 10+ years in clinical drug safety/pharmacovigilance, preferably in biotech or pharma; extensive experience in safety risk management, IND/BLA processes, and global safety regulations; oncology experience preferred; strong vendor oversight and cross-functional collaboration skills; proficiency with MedDRA, safety databases, and regulatory submissions. High-Value: oncology, drug safety, pharmacovigilance leadership, IND/BLA, global regulatory compliance, vendor management. WorkSetup: onsite 4 days/week in Brighton, MA.