Vice President, Head of Pharmacovigilance

About Apogee Therapeutics

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”

We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.

If this sounds like you, keep reading!

Role Summary

We are seeking a Vice President, Head of Pharmacovigilance. In this newly created position, you will be responsible for leading drug safety strategy and operations across Apogee’s pipeline. As a senior leader in the Clinical Development and Medical Affairs (CDMA) Organization, you will define pharmacovigilance policies, ensure regulatory compliance, and provide expert guidance on safety risk management. This role is critical in supporting regulatory approvals, patient safety, and long-term drug development strategies. Additionally, you will play a key role in the oversight and strategic direction of drug safety and pharmacovigilance activities to ensure high-quality data generation to support the safety and efficacy of our products in development.

Key Responsibilities

• Play a hands-on leadership role to build and manage Apogee’s global pharmacovigilance strategy in close collaboration with the Chief Medical Officer and the Head of Clinical Development and Medical Affairs.
• Oversee compliance with FDA, EMA, MHRA, PMDA and ICH pharmacovigilance requirements, overseeing adverse event reporting, safety update reports and risk management plans.
• Work cross functionally with clinical development, clinical operations, medical affairs, and commercial teams to provide expertise and integrate pharmacovigilance into broader corporate strategy.
• Represent the company in discussions with health authorities, responding to inquiries, audits, and inspections related to drug safety, and participate in EOP2 meetings and interactions.
• Oversee safety signal detection, aggregate analysis, risk evaluation, and mitigation strategies across the pipeline at all stages of development to determine benefit-risk profiles.
• Contribute knowledge of relevant drug class and/or competitor safety issues, and provide input to study related documents (i.e. protocols, IBs, DSURs/ASRs).
• Oversee PV Operations team responsible for case processing, aggregate safety reporting, and pharmacovigilance data analysis, ensuring operational excellence in drug safety surveillance. Oversee PV related vendor management.
• Lead and oversee the development of the Integrated Summary of Safety (ISS), and the safety-related components of the New Drug Applications (NDA), and Marketing Authorization Applications (MAA), in compliance with global regulatory standards.
• Review safety content of scientific publications such as posters, abstracts, and manuscripts.
• As Apogee grows build and lead a high-performing pharmacovigilance team, focused on delivering scientific rigor, compliance, and innovation.

Ideal Candidate

• MD degree is required
• Minimum 15+ years of pharmacovigilance experience in the b