[Hiring] Director, Pharmacovigilance Operations @Neurogene, Inc.

Role Description

The Director, Pharmacovigilance (PV) Operations is responsible for the strategic leadership, oversight, and execution of global pharmacovigilance operational activities supporting clinical development and future commercial products. This role serves as the operational leader of the PV function, ensuring a scalable, inspection-ready pharmacovigilance infrastructure that meets global regulatory requirements and supports the company's transition from development-stage to commercial-stage operations.

• Oversee PV vendors, safety systems, compliance activities, aggregate reporting operations, quality management, and process optimization.
• Work closely with Safety Physicians, Clinical Development, Regulatory Affairs, Quality, Medical Affairs, and external partners to ensure efficient and compliant execution of global safety activities while driving operational excellence and continuous improvement.

Qualifications

• Bachelor's degree in nursing, pharmacy, or related life sciences discipline; advanced degree preferred.
• 10+ years of pharmacovigilance experience within biotechnology, pharmaceutical, or CRO environments.
• 5+ years of leadership experience in pharmacovigilance operations, vendor management, or safety systems.
• US Licensure preferred.

Requirements

• Develop and execute the pharmacovigilance operational strategy to support ongoing clinical development programs and future commercial products.
• Establish scalable processes, governance structures, and operating models that support organizational growth.
• Establish and monitor key performance indicators (KPIs), escalate issues and drive Corrective and Preventive Actions (CAPAs) as warranted.
• Provide end-to-end oversight of pharmacovigilance vendors, including case processing, aggregate reporting, literature surveillance, safety systems, and call center providers, as applicable.
• Maintain a state of continuous inspection readiness across all pharmacovigilance activities.
• Serve as PV lead in preparation for regulatory inspections, partner audits, and due diligence assessments.
• Ensure effective oversight and inspection readiness of outsourced PV activities.
• Support vendor selection, qualification, contracting, and implementation activities.
• Partner with Quality Assurance to establish and maintain compliant pharmacovigilance processes, Standard Operating Procedures (SOPs), work instructions, and training programs.
• Provide operational oversight for the preparation and submission of aggregate safety reports and for safety updates supporting regulatory submissions and health authority interactions.
• Monitor incoming safety information from all sources and ensure operational support for signal detection, safety surveillance, and risk management activities.
• Participate in safety governance meetings.
• Partner closely with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Clinical Operations, Quality, and Medical Writing to ensure alignment of safety activities.
• Provide internal and external operational support for pharmacovigilance activities (e.g., investigator training and adverse event reporting training).
• Review safety-related sections of clinical development documents (e.g., protocol safety reporting language, alignment of patient Informed Consent with Investigator Brochure).
• Support regulatory submissions, product launches, business development activities, and partnership due diligence efforts.
• Support the development and compliant execution of Safety Data Exchange Agreements (SDEAs) with partners.
• Serve as business owner for pharmacovigilance systems and technologies.
• Oversee implementation, maintenance, enhancement, validation support, and governance of safety databases and related platforms.
• Drive operational excellence through process standardization, automation, and continuous improvement initiatives.
• Monitor evolving global PV regulations and ensure operational processes remain compliant.

Benefits

• Remote office-based work with some travel (<10%).