Senior Patient Safety and Pharmacovigilance Operations Specialist II

Role: Manager of Patient Safety & Pharmacovigilance (PSPV) Compliance, Standards, and Training, responsible for supporting PV compliance activities across investigational and marketed products. Core responsibilities include maintaining the PSPV Quality Management System, authoring and revising PV procedures per global regulations, developing and managing PV training programs, monitoring compliance metrics/KPIs, supporting inspection readiness, and managing deviation, CAPA, and change control processes. Qualifications: Bachelor's in life sciences or healthcare; at least 5 years in Patient Safety/PV with 2+ years in PV compliance or quality systems; strong knowledge of PV regulations such as FDA, EMA, ICH; experience with QMS systems (e.g., Veeva) is a plus; excellent organizational and communication skills. High-Value: PV compliance, global regulatory standards (FDA, EMA, ICH), quality management, inspection support, deviation and CAPA management. Work setup: headquarters-based in the U.S., with a salary range of $160,000–$200,000, dependent on experience.