Senior Director, Head of Pharmacovigilance Operations

Senior Director, Head of Pharmacovigilance Operations Build and lead the pharmacovigilance operations that carry Nurix's growing clinical portfolio toward commercialization. You'll own the end-to-end ICSR model, safety systems, vendor oversight, and inspection readiness, with the chance to set strategy while staying hands-on and to build the function and team from the ground up. Position Description The Opportunity Report to the Head of PV and define and execute the short- and long-term PVO strategy, goals, and operating model in alignment with the PV department and corporate objectives Grow, mentor, and develop the PVO team, setting priorities and ensuring coverage across a growing portfolio; partner with the Head of PV on departmental planning, headcount, and budget Provide PVO updates and escalate risks, issues, and compliance trends to PV and executive leadership as appropriate Oversee the end-to-end ICSR management framework (intake, processing, in-stream quality review, regulatory submission oversight, and retrospective quality review), ensuring timeliness, accuracy, and compliance with global regulations (21 CFR, EU GVP, ICH E2 series) Define, monitor, and report case processing metrics (KPIs/KQIs), drive root cause analysis and resolution of quality or timeliness issues, and oversee the drug safety mailbox Oversee SAE reconciliation with Clinical Operations and Data Management and Reference Safety Information (RSI) tracking and dissemination, and ensure PVO input into the safety content of clinical documents (protocols, ICFs, IBs/RSI, and CSRs) Ensure the integrity of safety data outputs from the Global Safety Database for aggregate reports, signal assessments, health authority requests, and other safety needs Oversee operational delivery of aggregate safety reports (e.g., DSUR, PBRER/PSUR), and partner with Medical Safety, Regulatory Affairs, and Biostatistics to support signal management and benefit-risk evaluation Own the strategy, validation, and lifecyc