[Hiring] Associate Director, Pharmacovigilance Regulatory Reporting & Submissions @Alnylam Pharmaceuticals

This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more. Role Description The Associate Director, Pharmacovigilance Regulatory Reporting & Submissions is responsible for the oversight of the processes and systems which enable reporting of Individual Case Safety Reports (ICSRs) to health authorities, Alliance Partners and Contract Research Organizations (CROs) in compliance with applicable global regulations and contractual obligations. • Oversee global ICSR reporting processes to regulatory authorities, Alliance Partners, Data Monitoring Committees (DMCs), Safety Reporting Committees (SRCs) and CROs in compliance with global and regional regulations. • Interpret and document ICSR reporting rules in the Alnylam reporting rules tracking repository and serve as Subject Matter Expert for ICSR reporting rules for all Alnylam products. • Verify and confirm the accurate configuration of reporting rules in the Global Safety Database and approve configuration requests. • Manage vendor relationships for ICSR reporting activities. • Drive automation and process improvements for safety data capture and reporting. • Partner with Clinical, Regulatory, Medical Affairs, and Quality teams to align safety reporting strategies. • Review and/or create metrics to measure reporting compliance to regulatory agencies, Alliance Partners, internal destinations, DMCs, SRCs, and CROs. • Serve as ICSR submission subject matter expert (SME) for audits and inspections. • Support NDA/MAA submissions with accurate and timely safety data. • Oversee the late ICSR process including investigations, root cause analysis and trending, correction development, and implementation. Qualifications • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field and/or a licensed healthcare professional (advanced degree preferred). • Minimum of 10 years of experience in pharmacovigilance/drug safety roles. • Strong knowledge of PV databases (e.g., Argus) and their applications. • Excellent leadership, project management, and vendor oversight skills; can establish and maintain effective relationships with customers (internal and external). • Excellent written and verbal communication skills. Able to express complex ideas. • Ability to work independently, prioritize effectively and work in a matrix team environment required. Requirements • #LI-JB1 • #LI-Remote Benefits • Comprehensive benefits including medical, dental, and vision coverage. • Life and disability insurance. • A lifestyle reimbursement program. • Flexible spending and health savings accounts. • 401(k) with a generous company match. • Paid time off, wellness days, holidays, and two company-wide recharge breaks. • Generous family resources and leave. Apply tot his job