Brief Description

Company Background

The mission of Neurogene is to treat devastating neurological diseases to improve the lives of patients and families impacted by these rare diseases. Neurogene is developing novel approaches and treatments to address the limitations of conventional gene therapy in central nervous system disorders. This includes selecting a delivery approach to maximize distribution to target tissues and designing products to maximize potency and purity for an optimized efficacy and safety profile. The Company’s novel and proprietary EXACT transgene regulation platform technology allows for the delivery of therapeutic levels while limiting transgene toxicity associated with conventional gene therapy. Neurogene has constructed a state-of-the-art gene therapy manufacturing facility in Houston, Texas. CGMP production of NGN-401 was conducted in this facility and will support pivotal clinical development activities. This transformative work is driven by our highly collaborative people who come together each day to bring us closer to achieving our mission. As an employee of Neurogene, you will be part of building a culture that honors patient and caregiver mindsets and nurtures innovation, creative problem solving and a strong sense of purpose.

Position Overview – REMOTE

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.

Requirements

Accountabilities and Responsibilities

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 (eg, 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

Minimum Requirements

Education

Bachelor's degree in nursing, pharmacy, or related life sciences discipline; advanced degree preferred

Experience

10+ years of pharmacovigilance experience within biotechnology, pharmaceutical, or CRO environments
5+ years of leadership experience in pharmacovigilance operations, vendor management, or safety systems

Licenses or Certifications

US Licensure preferred

Knowledge, Skills And Attributes

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 (eg, 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, as illustrated by the ability to instill a sense of pace and urgency into the team.
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.

Work Environment

Remote office-based work with some travel (

This job description has been developed based upon the expected and current duties, responsibilities and requirements for the position. Because job requirements evolve with the changing needs of Neurogene’s business, this description is subject to change and may be modified at any time, whether formally or informally.

Neurogene Inc. jobs

Director, Pharmacovigilance Operations

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