Executive Director, Pharmacovigilance Operations

Role Summary

The Executive Director, Pharmacovigilance Operations is responsible for building, leading, and overseeing the strategy, systems, and operational execution of global pharmacovigilance activities for pre- and post-marketing programs. This role ensures safety operations, case management, compliance oversight, signal management, and safety governance processes meet global regulatory requirements. The Executive Director will lead a growing PV Operations team, manage PV vendors, and collaborate with Clinical Development, Clinical Operations, Regulatory, Quality, Medical Affairs, and Market Access to maintain robust safety surveillance.

Responsibilities

• Strategic Leadership and Governance
  • Continue to evolve and execute the overarching strategy for global PV Operations in alignment with corporate objectives and regulatory expectations.
  • Establish and maintain the PV system, including quality governance, vendor oversight, and SOP frameworks.
  • Serve as a senior PV leader within safety governance committees, contributing to safety strategy, risk management, and decision-making.
  • Partner with Quality to ensure the organization remains inspection-ready and compliant with global GVP requirements.
• Safety Operations Management
  • Oversee vendors for global case processing (serious and non-serious), data entry, medical coding, quality review, and submission of expedited and periodic reports.
  • Direct signal management activities, including detection, assessment, documentation, and communication.
  • Ensure timely and compliant submission of ICSRs, DSURs, PSURs, and other regulatory deliverables.
  • Participate in Data Safety Monitoring Board activities, including provision of safety information for DSMB meetings and interim reviews.
  • Drive continuous improvement of PV workflows, data quality, and operational efficiency.
• PV Systems, Technology, and Vendor Oversight
  • Own the PV system architecture, including safety databases, reporting tools, and technology upgrades.
  • Oversee vendor selection and management for case processing, literature screening, signal detection tools, and call center services.
  • Ensure effective performance monitoring, metrics reporting, and issue resolution.
• Cross-Functional Collaboration and Communications
  • Partner with Regulatory Affairs, Clinical Operations and Development, Biometrics, Quality, Medical Affairs, and Market Access to align safety operations with clinical strategy and post-marketing obligations.
  • Provide senior-level PV operational guidance during inspections.
  • Communicate emerging safety issues, operational risks, and compliance gaps to senior leadership.
  • Work with device manufacturers to ensure appropriate compliance and safety of drug-device combinations.

Qualifications

• Bachelor’s degree in life sciences; advanced degree (PharmD, RN, MPH, MS, PhD) strongly preferred.
• Approximately 15+ years of progressive pharmacovigilance experience in the biotech or pharmaceutical industry, with significant leadership responsibility.
• Proven experience establishing or scaling PV operations, including global safety systems and vendor networks.
• Prior leadership of major PV regulatory submissions, audits, and health authority inspections.
• Experience in both clinical-stage and commercial-stage organizations strongly preferred; drug-device experience important.
• Deep understanding of global GVP requirements, FDA and EMA safety regulations, ICH guidelines, risk management planning, and signal detection methodologies.
• Expertise with safety databases (e.g., Argus, ArisGlobal, SafetyWorks), case processing workflows, and data quality controls.
• Ability to translate complex safety requirements into scalable operational frameworks.
• Exceptional ability to lead high-performing teams, manage change, and influence senior stakeholders.
• Strong vendor management, contract oversight, and operational governance skills.
• Ability to manage complex, global workloads with minimal oversight.
• Excellent verbal and written communication skills; strong analytical, prioritization, and problem-solving capabilities.
• High degree of independence, integrity, sound judgment, and commitment to compliance; strong interpersonal skills to work with multiple departments and vendors.
• Experience managing staff, contract service providers, external consultants, and in-house project teams.
• Hands-on troubleshooting ability and a self-starter mindset.
• Occasional travel required (less than 10%).

Education

• Bachelor’s degree in life sciences; advanced degree (PharmD, RN, MPH, MS, PhD) strongly preferred.

Additional Requirements

• Occasional travel required (less than 10%).