Vice President, Head of Pharmacovigilance

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.

Responsibilities

• Play a hands-on leadership role to build and manage Apogee‚Äôs 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.

Qualifications

• 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.

Skills

• Leadership and strategic thinking
• Regulatory affairs and pharmacovigilance operations
• Cross-functional collaboration
• Safety signal detection and data analysis
• Vendor and database management

Education

• MD degree

Additional Requirements

• Travel up to 20% as needed