Manager, Patient Safety & PV Compliance, Standards, and Training

Key Responsibilities Support operation and maintenance of the PSPV Quality Management System (QMS), ensuring consistent implementation aligned with regulatory requirements. Author, review, revise, and maintain PSPV procedures, work instructions, and controlled documents in compliance with global PV regulations (FDA, EMA, ICH). Develop, implement, and maintain role-based PV training programs (initial/refresher), including tracking training completion and related compliance KPIs. Develop, compile, and report PV compliance metrics/KPIs, including trend/performance assessment, compliance status, and improvement opportunities. Support PSPV inspection readiness (documentation preparation, mock inspections, support of regulatory inspections). Manage PSPV deviation, CAPA, and change control activities (investigation support, documentation, effectiveness checks). Monitor pharmacovigilance regulation/guideline changes and support procedural/training updates. Support review, update, and ongoing maintenance of the Pharmacovigilance System Master File (PSMF), coordinating routine reviews and updates across functions and vendors. Required Skills and Qualifications Ability to operate effectively in a regulated, fast-paced environment while managing multiple priorities. Strong working knowledge of pharmacovigilance regulations and guidelines (FDA, EMA, ICH). Experience with Quality Management Systems (e.g., Veeva or similar) (plus). Strong organizational, documentation, and attention-to-detail skills. Effective written and verbal communication skills; ability to collaborate cross-functionally and with external vendors. Education and Experience Bachelor’s degree in life sciences/healthcare/related field; advanced degree (e.g., RN, BSN, PharmD) preferred. Minimum 5 years Patient Safety/PV experience, including 2+ years in PV compliance, standards, training, or quality system activities. Experience managing quality events (deviations, CAPAs, change controls). Inspection/audit support experience and project management skills (preferred). Applicants must be currently authorized to work in the United States on a full-time basis. #J-18808-Ljbffr Scorpion Therapeutics