Vice President, Head of Pharmacovigilance

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 biopharmaceutical industry
• Must be a self-starter willing to play a hands-on role in establishing the PV function
• Strong expertise in global regulatory requirements (FDA, EMA, MHRA, PMDA, ICH)
• Exposure to biologics, medications for I&I conditions including dermatology a plus
• Experience in the following areas are required:
• leading regulatory submissions, including the ISS, and safety related sections of the NDA and MAA as well as label development
• interacting with regulatory agencies on safety-related matters, including FDA and EMA negotiations and EOP2 meetings and interactions
• managing safety databases, case management systems, and pharmacovigilance software
• Strong leadership and communication skills, ability to influence and define corporate safety policies
• Alignment with Apogee C.O.R.E. (Caring, Original, Resilient and Egoless) values
• Position requires up to 20% travel to company and team meetings, conferences, etc.

The anticipated salary range for candidates for this role will be $375,000 - $425,000/year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.