Associate Director/Director, Drug Safety & Pharmacovigilance (Quality & Compliance)

Associate Director/Director of Drug Safety & Pharmacovigilance (PV) Quality & Compliance Responsibilities Provide strategic guidance and leadership to the pharmacovigilance quality assurance team. Develop and implement a comprehensive QA strategy aligned with organizational goals. Develop/oversee end-to-end PV QA processes and systems to ensure regulatory and internal compliance. Provide GVP support for clinical, post‑marketing, and commercial activities, protecting patient safety, maintaining data integrity, and supporting Quality Systems. Monitor industry trends, regulatory changes, and best practices for continuous improvement. Monitor vendor KPI metrics and improve CRO/vendor quality. Develop, review, and maintain PV QA Standard Operating Procedures (SOPs). Manage and develop a team (training, mentoring, performance evaluations). Conduct internal audits of PV processes, systems, and data; collaborate with internal/external teams during inspections. Develop quality metrics; prepare quality reports for senior management. Assess and manage PV‑related risks with cross‑functional teams. Drive continuous improvement; reassess initiatives for effectiveness and adjust strategy. Monitor regulatory intelligence affecting PV systems. Oversee CAPA development, execution, closure, and escalation as needed. Support drug safety/issue management for early issue detection and CAPA effectiveness. Requirements 10+ years pharmacovigilance/drug safety; 9–10 years in QA/compliance. Bachelor’s degree in a related scientific field. Strong understanding of global PV regulations, guidelines, and best practices. Proven leadership and team management experience. Excellent written/verbal communication across cross‑functional teams and stakeholders. Detail‑oriented; strong analytical and problem‑solving skills. Experience with internal audits and regulatory inspections desirable. Proficiency with pharmacovigilance databases and software. Preferred Advanced degree in pharmacy, life sciences, or related field. California pay range: $180,000–$230,000 USD #J-18808-Ljbffr