Senior Director, Head of PV Science

Role: Senior Director of PV Science and Aggregate Reports leading pharmacovigilance (PV) for Alnylam's RNAi therapeutics portfolio. Responsibilities: oversee PV science team and aggregate reports team, manage safety profiles across all product lifecycle stages, ensure timely production of aggregate safety reports (DSURs, PSURs) for regulatory submission, and develop risk management strategies. Collaborate closely with Medical Safety and Risk Management, study teams, and external partners to implement PV processes, optimize signal detection, and support safety communication activities. Lead safety committee operations, participate in audits, and drive process improvements. Qualifications: Master’s or Doctorate in a medical or healthcare discipline (e.g., MD, PharmD, RN), minimum 12 years in pharma, 8+ years in drug safety, with at least 5 years managing teams. Preferred: experience in RNAi therapeutics, rare diseases, global safety regulations (US, EU, LATAM, APAC), and safety database tools (Argus, Empirica). High-Value: PV leadership in biopharma, safety reporting including aggregate reports, risk management, regulatory compliance, and cross-functional collaboration in a global, innovative biotech setting. Work setup: hybrid (onsite 2 days/week) in Cambridge or Philadelphia.