Executive Director, Pharmacovigilance Operations

Executive Director, Pharmacovigilance Operations

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Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes.

Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.

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 for Liquidia. Reporting to the Head of Regulatory Affairs and PV, this role ensures that safety operations, case management, compliance oversight, signal management, and safety governance processes meet all global regulatory requirements. The Executive Director will lead a growing PV Operations team, manage PV vendors, and collaborate closely with Clinical Development, Clinical Operations, Regulatory, Quality, Medical Affairs, and Market Access to ensure the development and maintenance of a robust safety surveillance

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.
• Partnering with Quality, 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 Individual Case Safety Reports (ICSRs), Development Safety Update Reports (DSURs), Periodic Safety Update Reports (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.
• Communicate emerging safety issues, operational risks, and compliance gaps to senior leadership.
• Partners closely with device manufacturers to ensure appropriate compliance and safety of drug-device combinations.

Education and Experience

• Bachelor’s degree in life sciences; advanced degree (Pharm
  
  D, 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…