Senior Director, Drug Safety and Pharmacovigilance Operations
Spyre Therapeutics, Inc.
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 #J-18808-Ljbffr Spyre Therapeutics, Inc.
Vacancy posted 4 days ago
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