Senior Director, Drug Safety and Pharmacovigilance Operations

Role: Senior Director, Drug Safety and Pharmacovigilance (DSPV) Operations, providing leadership for global pharmacovigilance activities within a biopharma focused on immunology therapeutics, including antibody programs. Responsibilities: oversee case management, safety database operations (Argus), vendor governance, regulatory compliance, PV QMS, inspection/audit readiness, safety data reporting, and training; manage budgets and contracts; ensure safety systems, documentation, and business continuity. Requirements: Master’s in life sciences or related field; 8+ years in pharmacovigilance, with hands-on experience with safety databases (preferably Argus), safety-data analytics, and global safety reporting (DSURs, 6MLLs); strong knowledge of ICH guidelines and US/EU regulations; proven vendor and audit management skills. HighValue: biologics/antibodies, immunology (α4β7, TL1A, IL-23, IL-17A/F targets), clinical-stage programs, global safety compliance, PV quality systems, inspection readiness, database oversight, remote work with global collaboration, no specific travel requirement stated.