Senior PV Associate II

Role: Support pharmacovigilance activities for post-marketing safety of Madrigal’s MASH therapeutic, Rezdiffra. Responsibilities: oversee vendor safety assessments, perform quality checks on ICSRs, review safety reports including narratives and causality, track safety metrics, ensure compliance with global regulations, and assist with audits and inspection readiness. Requirements: bachelor’s in a scientific field; minimum 3 years postmarketing PV experience; familiarity with ICSR processing, safety databases (e.g., Argus, ARISg), MedDRA, and pharmacovigilance regulations (ICH, FDA, EMA). Preferred: clinical experience such as RN, BSN, or PharmD. High-Value: postmarketing surveillance, safety data review, regulatory compliance, global safety standards, and vendor management in a biotech context. Work setup: not specified, likely hybrid or office-based; travel not indicated.