Job DescriptionDescription: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.
QualificationsEducation:- Bachelors Degree (BA/BS) Bachelor's degree in Life Sciences, Pharmacy, Nursing, Public Health, or related discipline required. - Required
- Master Degree (MS/MA) Advanced degree (MS, MPH, MBA, or equivalent) - Preferred
Experience:- 10 years or more in 10 plus years of pharmacovigilance experience.
- 5 years or more in 5 plus leadership experience in PV Compliance, Quality, or Safety Operations.
Specialized Knowledge:- Extensive experience managing health authority inspections and PV audits.
- Experience with global pharmacovigilance regulations and quality systems.
- Experience managing vendors, business partners, and SDEAs.
The base salary for this position ranges from $160,000 - $185,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.
At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.
