Associate Pharmacovigilance Compliance Director

Description:

The Associate Director of PV Compliance is responsible for leading the Global Patient Safety (GPS) compliance and quality management program to ensure adherence to global pharmacovigilance (PV) regulations, company procedures, and industry best practices. Reporting to the VP, Global Patient Safety and Risk Management, this role provides strategic oversight of PV compliance, audits and inspections, quality systems, vendor management, Safety Data Exchange Agreements (SDEAs), CAPA processes, training compliance, and SOP governance.

Essential Functions:

• Lead the Global Patient Safety compliance program and quality management activities. Develop and maintain a risk-based compliance oversight framework. Monitor compliance with global pharmacovigilance regulations and company procedures. Drive continuous improvement initiatives across the PV system. Identify opportunities for process optimization and implement best practices related to intake of Adverse Events, Product Quality Complaints and Medical/Product Inquiries. Stay current with industry trends and regulatory changes, adjusting processes accordingly. Manage the Regulatory Intelligence Monitoring process by staying informed about pharmacovigilance regulations and guidelines to ensure compliance in all intake activities. Assist in the preparation of documentation for regulatory submissions and Information.
• Audits and Inspections- Lead and coordinate all pharmacovigilance audits and health authority inspections. Maintain inspection readiness programs and inspection support processes. Manage audit responses, observations, CAPAs, and effectiveness checks. Coordinate inspection preparation activities across GPS and cross-functional teams.
• SDEA Management and Business Partner Oversight- Oversee Safety Data Exchange Agreement (SDEA) lifecycle management. Ensure agreements accurately reflect regulatory and operational requirements. Lead periodic business partner compliance reviews. Oversee business partner reconciliation activities and compliance monitoring.
• CAPA Management- Manage the CAPA process, including identifying root causes, implementing corrective actions, and ensuring timely resolution of issues. Oversee deviation management, ensuring that all deviations are documented, investigated, and appropriately addressed.
• Quality Oversight- Provide independent quality oversight of: Individual Case Safety Reports (ICSRs), Non-Case determinations, PADERs and aggregate reports. Literature surveillance activities and vendor deliverables. Lead PV vendor qualification and oversight activities. Manage vendor audits, governance meetings, and performance reviews. Monitor vendor compliance with contractual obligations and regulatory requirements.
• Metrics and Compliance Monitoring- Establish and maintain GPS compliance metrics and KPIs. Monitor performance trends and identify compliance risks. Develop executive dashboards and leadership reporting packages. Oversee call center compliance metrics and performance monitoring.
• Training and SOP Governance- Manage GPS training compliance programs. Monitor adverse event training completion and effectiveness. Develop compliance-related training materials. Oversee SOP lifecycle management including development, review, implementation, and periodic review.

Additional Responsibilities:

• 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.