[Hiring] Director, Pharmacovigilance Operations @Neurogene

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.

The incumbent will oversee PV vendors, safety systems, compliance activities, aggregate reporting operations, quality management, and process optimization. Working closely with Safety Physicians, Clinical Development, Regulatory Affairs, Quality, Medical Affairs, and external partners, this individual will 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

• Strong working knowledge of global pharmacovigilance regulations, including FDA, EMA, ICH, and GVP requirements
• Experience overseeing outsourced pharmacovigilance models and vendor governance
• Experience supporting regulatory inspections, audits, and quality management activities
• Experience implementing or managing Argus, ARISg, Veeva Safety, or comparable safety systems
• Experience supporting commercial launch readiness activities
• Excellent oral and written communication skills
• Outstanding interpersonal skills and ability to develop a rapport with cross-functional partners that enable highly effective collaboration
• Flexibility in a changing environment (e.g., balancing individual priorities vs evolving organizational needs)
• Ability to act expeditiously with deliberateness and intention
• Continuous strong focus on meeting or exceeding expectations in executing deliverables, performance, and results
• Ability to track and measure performance against defined metrics
• Self-starter with high degree of energy, independence, initiative, and self-motivation
• Someone who moves fast and decisively in a balanced manner, with a passion for the growing company
• Passionate, collaborative, creative, willing to take prudent risks, and motivated by the creation of a company focused on transformative treatments for patients and their families

Benefits

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