Associate Director, Pharmacovigilance Operations

Role: Associate Director, Pharmacovigilance Operations, responsible for PV compliance and operational management across Nurix's product lifecycle, from FIH to post-marketing. Responsibilities include leading PV activities for assigned products, overseeing ICSR management, safety data review, regulatory submission support, vendor oversight, and ensuring inspection readiness. Key functions involve cross-functional collaboration with Clinical Operations, Data Management, Regulatory Affairs, and Medical Safety, as well as developing PV systems and SOPs. Requirements: Bachelor's degree in Life Sciences or related field; 8–10+ years in pharmacovigilance/drug safety; experience managing PV vendors and supporting regulatory audits; proficiency with global PV regulations, safety databases (e.g., Argus), and safety reporting workflows. Preferred qualifications include advanced degrees (PharmD, MS, PhD) and experience in full product lifecycle management. High-Value: managing PV operations for biologics or small molecules, supporting regulatory inspections (FDA, EMA), and overseeing safety data for clinical and post-market phases. Work setup: onsite in Brisbane, CA, with an emphasis on collaboration, results focus, and resourcefulness.