Vice President, Pharmacovigilance and Drug Safety

1w1 week ago

Immunome, Inc.

Bothell, US · Full-time · $364,000 – $433,000

About this role

Immunome is a clinical-stage targeted oncology company developing first-in-class and best-in-class targeted cancer therapies. The Vice President, Pharmacovigilance & Drug Safety serves as the global safety leader for Immunome’s pipeline, reporting directly to the Chief Medical Officer. This role provides strategic vision and operational oversight across drug safety, signal detection, and risk management while ensuring worldwide regulatory compliance.

The executive oversees collection, analysis, and reporting of safety data from clinical trials and leads development of drug safety databases and procedures. Responsibilities include preparing Periodic Safety Update Reports and safety analyses for NDAs, BLAs, and MAAs. Expert safety guidance supports protocol development and site-facing documents.

Build and lead a best-in-class pharmacovigilance team partnering cross-functionally with Clinical Development, Regulatory Affairs, and Quality Assurance. Conduct training on pharmacovigilance practices and regulatory updates. Analyze safety data trends to deliver actionable insights to senior management.

Represent pharmacovigilance in regulatory authority meetings and audits while providing medical expertise for safety event evaluations. Drive risk management strategies throughout the product lifecycle. Enable advancement of innovative oncology programs from early development through commercialization.

Requirements

M.D., D.O., or equivalent advanced degree in life sciences or pharmacology required; additional training in oncology or drug safety highly preferred
Minimum of 10 years pharmacovigilance and drug safety experience in biotech/pharma, including 5 years in senior leadership with global responsibilities
Strong knowledge of global pharmacovigilance regulations including FDA, EMA, ICH, MHRA, PMDA
Proven track record managing safety data, signal detection, benefit-risk assessment, and risk management strategies
Demonstrated ability to build and lead a highly functioning pharmacovigilance team

Responsibilities

Develop and implement pharmacovigilance strategy aligned with regulatory requirements and company goals
Build and develop a team of drug safety professionals to evaluate and oversee safety reporting
Oversee collection, analysis, and reporting of safety data from ongoing clinical trials
Lead preparation and submission of safety reports including Periodic Safety Update Reports
Lead safety analysis for regulatory submissions including NDAs, BLAs, and MAAs
Ensure compliance with global regulatory requirements including FDA, EMA, and ICH
Collaborate with Clinical Development, Regulatory Affairs, and Quality Assurance teams
Provide expert guidance on risk management and mitigation strategies throughout product lifecycle