Associate Director, Pharmacovigilance Operations

Associate Director, Pharmacovigilance Operations

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements.

Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.

The Associate Director, Pharmacovigilance Operations (PVO) is responsible for all PV operational and compliance aspects of assigned Nurix products across the product lifecycle — from First-In-Human (FIH) studies through post-marketing — and for oversight of the end-to-end management of Individual Case Safety Reports (ICSRs).
This role serves as the PVO lead for assigned products, driving in-stream quality review, regulatory submission oversight, retrospective quality review, and reconciliation activities, while partnering cross-functionally with Clinical Operations, Data Management, and Regulatory Affairs. The role also provides vendor oversight, supports audit and inspection readiness, and contributes to the development of PV infrastructure, systems, and processes.

• Serve as the PVO Lead for assigned products, representing PV operations in cross-functional clinical team meetings.
• Support SAE reconciliation activities in partnership with Clinical Operations and Data Management.
• Track and manage Reference Safety Information (RSI) updates and ensure timely dissemination across study teams and systems.
• Contribute to the safety content of clinical study documents, including Study Protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), Investigator Brochures (IB)/RSI, and other relevant study documentation.
• Maintain accountability for the data integrity of safety data outputs from the Safety Database for aggregate reports, Health Authority requests, and other safety requirements.
• Manage the drug safety mailbox.

• Own end-to-end ICSR management, including in-stream quality review, regulatory submission oversight, and retrospective quality review to ensure timeliness, accuracy, and compliance with global regulations.
• Generate reports and listings/line-listings (LLs) from the Global Safety Database (GSDB) to support SAE reconciliation, Analysis of Similar Events (AOSE), Safety Signal Assessment Reports, and Aggregate Safety Reports (ASRs).
• Monitor case processing metrics and drive resolution of quality or timeliness issues.

• Partner closely with Clinical Operations, Data Management, Regulatory Affairs, and Medical Safety to ensure alignment on safety data flow, reconciliation, and reporting timelines.
• Act as a key liaison between PV and other functions for assigned products throughout the product lifecycle.

• Provide oversight of outsourced PV activities and vendors, establishing and monitoring key quality and compliance metrics (KPIs/KQIs).
• Ensure vendor performance aligns with contractual, quality, and regulatory expectations; drive corrective actions as needed.
• Support management of PV Agreements/Safety Data Exchange Agreements (SDEAs) with license partners.

• Participate in and support internal audits, regulatory inspections, and…