Associate Director, Pharmacovigilance

Position Summary

The Associate Director of Pharmacovigilance (PV), U.S. is responsible for leading safety and risk management activities for pharmaceutical products and medical devices throughout their life cycle. This role ensures compliance with U.S. and global regulatory requirements and internal standards, while collaborating with cross-functional teams to uphold patient safety and product integrity. The Associate Director will provide strategic leadership in adverse event monitoring, assessment, and reporting, ensuring PV operations align with industry best practices and corporate goals.

Key Responsibilities

Pharmacovigilance Leadership

• Lead PV activities for assigned products in the U.S., ensuring compliance with FDA, EMA, and internal procedures.
• Contribute to building the U.S. PV function and foster strong collaboration with headquarters and local teams (e.g., Regulatory, Quality).
• Oversee timely collection, processing, and reporting of adverse events (SAEs and NSAEs).
• Review and evaluate safety data to detect trends or signals, escalating critical issues as appropriate.

Safety Risk Management

• Direct the development and implementation of Risk Management Plans (RMPs), REMS, and other safety strategies.
• Collaborate with internal and external stakeholders to evaluate and mitigate product-related safety risks.

Regulatory Compliance

• Ensure adherence to all applicable PV and medical device regulations (e.g., ICH E2E, FDA, EMA, and U.S. laws).
• Monitor regulatory changes and contribute to continuous improvement of the PV system.
• Prepare and submit periodic safety reports (e.g., PADERs, Annual Reports) in coordination with Regulatory Affairs.

Cross-Functional Collaboration

• Partner with Clinical Development, Medical Affairs, Regulatory, and Quality teams to support safety assessments and product development.
• Provide safety input for clinical trials, marketing applications, and other regulatory submissions.

Training and Organizational Development

• Deliver training on local PV regulations and share insights from FDA inspections and industry experience.
• Support the development of internal PV capabilities and team knowledge.

Vendor Oversight

• Manage third-party vendors and CROs involved in PV activities.
• Ensure external partners meet safety, contractual, and regulatory obligations.

Data Management and Reporting

• Ensure data accuracy and quality in PV systems; lead initiatives to enhance data integrity.
• Oversee preparation of safety reports and contribute to the overall safety profile of products.
• Participate in due diligence activities, particularly for U.S.-based products.

Audits and Inspections

• Lead or support internal and external PV audits and FDA inspections.
• Implement corrective actions and drive continuous improvement in PV processes.
• Note: This list is not exhaustive. Additional responsibilities may be assigned based on business needs and evolving priorities.

Qualifications & Experience

• Advanced degree (PhD, PharmD, MD) in life sciences, pharmacology, or a related field-or equivalent experience.
• 8-10+ years of experience in pharmacovigilance or drug safety.
• Strong knowledge of U.S. and international PV regulations (e.g., FDA, ICH).
• Experience with adverse event reporting systems, PADERs, annual reports, and signal detection.
• Proven ability to lead cross-functional initiatives and support audits/inspections.
• Excellent communication, presentation, and stakeholder engagement skills.
• Strong organizational and project management capabilities.
• Analytical mindset with the ability to interpret safety data and provide actionable insights.
• Experience working in global, matrixed environments.