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.

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [email protected]. Requests will be handled confidentially and in accordance with applicable laws. 

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

 

Key roles that the Human Resources team performs:

 

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

 

Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

 

Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

 

Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.

 

Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.