Medical Director, Pharmacovigilance

Role: Medical Director of Pharmacovigilance overseeing safety activities for investigational and marketed products, primarily supporting Phase 3 clinical trials. Responsibilities: lead safety surveillance, signal detection, benefit-risk assessments, aggregate safety reporting (DSURs, PSURs, IND reports), medical review of adverse events, vendor oversight, and safety strategy development. Collaborate closely with clinical development, regulatory, medical affairs, and external CROs; contribute to safety documentation and regulatory responses; mentor team members. Requirements: MD degree; 7+ years in pharmacovigilance with experience in safety reporting, signal detection, case review, and regulatory submissions; deep knowledge of FDA, EMA, ICH guidelines, and GxP standards; proficiency with safety databases like Argus, MedDRA, WHO Drug Dictionary; understanding of clinical development lifecycle. Preferred: experience with risk management, safety governance, and cross-functional communication. HighValue: senior pharmacovigilance leadership supporting global regulatory compliance, with significant engagement in Phase 3 trials, safety strategy, and vendor management. Work setup: remote or Waltham, MA, with approximately 10-15% travel.