Director, Pharmacovigilance

Role: Lead pharmacovigilance for Beam's innovative gene editing therapeutics, providing strategic and operational safety support across the product lifecycle. Responsibilities: oversee safety monitoring, case assessments, safety report submissions, signal detection, vendor management, and safety governance activities; develop and review PV-related documentation; support inspection readiness and compliance; contribute to PV process improvements and cross-functional collaboration with Clinical Operations, Regulatory, Medical, and Data Management teams. Qualifications: Bachelor's or higher in Pharmacy, Nursing, Epidemiology, or Biosciences; 10+ years in pharma/biotech with at least 5 years in PV; strong knowledge of global PV regulations (FDA, EU, GVP, ICH), safety databases (ARGUS, ARISg), and clinical safety assessment; experience in safety reporting, signal detection, and PV systems. High-Value: focus on cutting-edge gene editing therapies, with PV expertise supporting clinical and post-marketing phases; experience with safety data review, aggregate reports (DSURs, PSURs), vendor oversight, and safety documentation. Work Setup: Onsite 1-3 days/week; some travel may be required.