Senior Director, Head of Pharmacovigilance Operations
Nurix Therapeutics
Nurix Therapeutics seeks a Senior Director to establish and lead pharmacovigilance operations for its expanding clinical pipeline. The role encompasses ICSR management, safety systems, vendor oversight, team building, and regulatory compliance across global markets.
Responsibilities
- Define and execute pharmacovigilance operations strategy, goals, and operating model aligned with department objectives
- Build, mentor, and manage the pharmacovigilance operations team across growing clinical portfolio
- Oversee end-to-end ICSR management including intake, processing, quality review, and regulatory submissions
- Lead vendor and CRO oversight with governance frameworks, KPIs, and performance management
- Own global safety database strategy, validation, system selection, and lifecycle management
Requirements
- Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field
- Extensive pharmacovigilance operations experience in clinical or commercial settings
- Expertise in ICSR management, global safety databases, and regulatory compliance (21 CFR, EU GVP, ICH E2)
- Demonstrated leadership and team development capabilities
- Knowledge of safety systems, vendor management, and inspection readiness
- Experience with PV system implementation and automation projects
Vacancy posted 2 days ago
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