Pharmacovigilance Manager - Benefit Risk

Job description

Pharmacovigilance Manager – Benefit Risk  Position Summary The Pharmacovigilance (PV) Manager – Benefit Risk is a senior safety professional responsible for leading and overseeing benefit-risk evaluation activities across assigned products and client portfolios. This role ensures the continuous assessment of product safety profiles through structured signal evaluation, safety data analysis, and integrated benefit-risk assessments in compliance with global regulatory requirements, including ICH E2E, ICH E2C(R2), EMA GVP Modules V and IX, and FDA guidance.  The PV Manager – Benefit Risk acts as a subject matter expert in benefit-risk methodology, collaborating cross-functionally with signal management, aggregate reporting, medical review, clinical, and regulatory teams to support proactive safety surveillance and informed decision-making throughout the product lifecycle.  Essential Functions Education Advanced degree in life sciences, pharmacy (PharmD), or medicine (MD) preferred. Additional qualifications in pharmacoepidemiology, biostatistics, or regulatory affairs are an advantage. Experience Minimum 5 years of pharmacovigilance experience, with at least 2–3 years focused...