Associate Pharmacovigilance Compliance Director
HybridBridgewater, New Jersey, United States
Job Summary
Lead the Global Patient Safety compliance program and quality management activities by developing a risk-based oversight framework and monitoring adherence to global pharmacovigilance regulations. Coordinate all pharmacovigilance audits and health authority inspections, manage CAPA processes, and oversee Safety Data Exchange Agreement lifecycle management. Provide independent quality oversight of Individual Case Safety Reports, vendor deliverables, and training compliance while establishing executive dashboards for performance metrics. Stay current with industry trends and regulatory changes to drive continuous improvement initiatives across the PV system.
Required Qualifications
- Strong understanding of FDA, EMA, MHRA, and global PV regulations
- Expertise in pharmacovigilance quality systems and inspection readiness
- Strong analytical and problem-solving skills
- Excellent leadership, communication, and stakeholder management abilities
- Experience with safety databases and compliance metrics reporting
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