Senior Director, PV Ops — Strategic Leader (Remote)

NURIX; San Francisco (CA); Vor Ort; USD 288.000 - 326.000; Vollzeit

Zusammenfassung

Nurix Therapeutics in Brisbane, CA is seeking a Senior Director, Head of Pharmacovigilance Operations to build and lead the PV organization, owning end-to-end ICSR, safety systems, vendor oversight, and inspection readiness. You will define strategy, hire and mentor the team, and partner with executive leadership to align PV with company objectives.

You’ll drive KPI/KQI reporting, oversee SAE reconciliation, manage safety data outputs, and steward GSD/RSI, SDEAs, and PV agreements.

Qualifikationen

• 12+ years pharmacovigilance/drug safety experience, with leadership in PV operations.
• Experience building, scaling, or transforming PV operations, ideally in a growing biotech environment.
• Experience managing PV vendors and CROs, including KPI/KQI development, governance, and performance management.
• Experience owning PV budgets, forecasting, and invoicing.
• Experience leading or supporting regulatory inspections and CAPA management.
• Experience with safety database implementations, upgrades, or transitions.

Aufgaben

• Define and execute short- and long-term PVO strategy and operating model.
• Grow, mentor, and develop the PVO team; manage headcount and budget.
• Oversee end-to-end ICSR management and compliance with global regs.
• Own strategy and lifecycle of Global Safety Database and PV systems.
• Lead PV agreements and SDEAs with partners; governance and vendor oversight.
• Lead inspection readiness and support regulatory inspections.

Kenntnisse

Leadership

PV operations

ICSR management

Vendor management

Regulatory inspections

Budget forecasting

SOP/GxP documentation

Strategic planning

Communication with execs

Project management

Ausbildung

Bachelor's degree in Life Sciences or related field

PharmD / MS / PhD / MBA preferred

Tools

Argus Safety

E2B gateway

Safety database migrations

CAPA tools

Jobbeschreibung

Nurix Therapeutics in Brisbane, CA is seeking a Senior Director, Head of Pharmacovigilance Operations to build and lead the PV organization, owning end-to-end ICSR, safety systems, vendor oversight, and inspection readiness. You will define strategy, hire and mentor the team, and partner with executive leadership to align PV with company objectives.

You’ll drive KPI/KQI reporting, oversee SAE reconciliation, manage safety data outputs, and steward GSD/RSI, SDEAs, and PV agreements.