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Brisbane, California, United States
Onsite
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.
Position:
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.
Responsibilities:
PV Operations for Clinical Study Management
• 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.
ICSR Management & Case Processing Oversight
• 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.
Cross-Functional Collaboration
• 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.
Vendor Oversight
• 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.
Audits, Inspections & Compliance
• Participate in and support internal audits, regulatory inspections, and associated CAPA development and tracking.
• Build and maintain PV infrastructure, systems, and processes to ensure inspection readiness and launch readiness in compliance with global PV regulations and guidelines (e.g., FDA, EMA, ICH).
• Develop and maintain PV operations and compliance related SOPs and work instructions.
Strategic & Departmental Contributions
• Develop short- and long-term goals for the PVO function in alignment with broader departmental and organizational objectives.
• Lead or contribute to PVO-related initiatives, process improvements, and system implementations as assigned.
• Perform other duties as required.
Requirements:
Education & Experience
• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field required; advanced degree (PharmD, MS, PhD) preferred.
• Minimum of 8–10 years of pharmacovigilance/drug safety experience, including significant experience in PV operations, ICSR management, and clinical safety support.
• Prior experience managing or overseeing PV vendors/CROs required.
• Experience with managing PV budget and invoicing.
• Experience supporting regulatory inspections and audits (FDA, EMA, or other health authorities) strongly preferred.
• Experience across the full product lifecycle (clinical development through post-marketing) preferred.
Knowledge, Skills & Abilities
• Strong working knowledge of global PV regulations and guidelines (21 CFR, EU GVP, ICH E2 series, GVP Modules).
• Hands-on experience with Global Safety Databases (e.g., Argus Safety, or equivalent) and case processing/reporting workflows.
• Demonstrated experience with SAE reconciliation, RSI tracking, and aggregate safety reporting.
• Strong vendor management skills, including KPI/KQI development and performance oversight.
• Excellent cross-functional collaboration and communication skills, with the ability to work effectively with Clinical Operations, Data Management, Regulatory, and Medical Safety teams.
• Strong analytical, organizational, and project management skills; able to manage multiple products/priorities simultaneously.
• Experience authoring or contributing to SOPs, work instructions, and PV process documentation.
• Detail-oriented with a strong quality and compliance mindset; experience preparing for and supporting inspections/audits.
Salary Range: $229,500 - $255,867
Location: Onsite - Brisbane, California
Fit with Nurix Culture and Values
• Strong team orientation; highly collaborative
• Solutions and results-oriented focus
• Hands-on approach; resourceful and open to diverse points of view
