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