Director / Senior Director, Pharmacovigilance Operations

Role: Lead and oversee pharmacovigilance operations for Rezolute’s late-stage biopharmaceuticals, supporting clinical development through to commercialization and post-marketing surveillance. Responsibilities: develop PV strategy, establish scalable PV systems, serve as safety SME across functions, manage signal detection, benefit-risk assessments, vendor oversight, and ensure regulatory compliance. Lead PV readiness for product launch, develop safety processes for adverse event intake, and maintain inspection readiness. Partner with quality, medical, regulatory, and external stakeholders to ensure PV excellence. Qualifications: advanced degree in health/sciences (MD, PharmD, PhD, RN/NP) with 10+ years (Director) or 12-15+ years (Senior Director) in pharma/biotech, including PV leadership, late-phase clinical support, and vendor management. Experience with NDA/BLA/MAA submission, rare disease or oncology focus preferred. Skills include global PV regulations, safety database systems (Oracle Argus or equivalent), signal detection, risk management, and cross-functional influence. HighValue: rare metabolic and endocrine disorders, hyperinsulinism, tumor-related hypoglycemia, late-stage development, regulatory submission, commercial launch, PV system build-out, global compliance, and vendor oversight. Work setup: not specified; likely hybrid or remote with leadership responsibilities spanning clinical to commercial phases.