Associate Director or Director of Pharmacovigilance Operations

Role: Associate Director/Director of Pharmacovigilance (PV) Operations, focused on scaling PV infrastructure and processes as Compass transitions from clinical to commercial stage. Responsibilities: lead PV system design, implementation, and ongoing maintenance for post-market safety, support regulatory submissions (NDA/MAA), manage vendor performance, and oversee PV compliance, audit readiness, and inspection preparation. Collaborate cross-functionally with Clinical Development, Regulatory, Medical Affairs, and Quality; author safety documentation; establish PV governance; optimize safety databases; and coordinate safety data exchange agreements. Qualifications: Bachelor’s in nursing, pharmacy, or related healthcare field (Master’s preferred); 8+ years in PV with biotech/pharma, 12+ years for senior roles; experience supporting clinical-to-commercial transition and vendor oversight; deep knowledge of global PV regulations (FDA, EMA, ICH, GVP) and safety databases (Argus/ArisG, Medidata Rave). Preferred: oncology experience, prior small company experience, and proven leadership in PV system implementation. HighValue: oncology, post-approval PV, regulatory inspection readiness, vendor management, global safety system expertise. Work setup: onsite in Brighton, MA, 4 days/week.