Medical Director Pharmacovigilance

Role Summary

We are seeking a Medical Director, Pharmacovigilance to join the Apogee Clinical Development team. In this newly created position, you will be responsible for safety aspects across Apogee’s pipeline. This role is critical in supporting regulatory approvals, patient safety, and long-term safety input into life-cycle management. Additionally, you will play a key role in supporting drug safety and pharmacovigilance activities to ensure high-quality data generation to support the safety and efficacy of our products in development.

Key Responsibilities

• Identify emerging safety signals and ensure appropriate escalation through internal safety governance pathways.
• Contribute to the development and execution of pharmacovigilance strategies for Apogee clinical programs across various stages of development.
• Maintain ongoing benefit–risk assessments incorporating disease severity, unmet medical need, and emerging clinical data.
• Collaborate with Regulatory Affairs to develop responses to any safety related regulatory agency inquiries.
• Ensure high-quality MedDRA coding, appropriate event characterization, and robust safety narratives.
• Lead preparation and review of DSURs, Investigator’s Brochures (IBs), safety sections of protocols, informed consent forms (ICFs), and clinical study reports.
• Provide safety input to regulatory submissions (INDs/CTAs), protocol amendments, and responses to health authority inquiries.
• Partner with Regulatory Affairs and Quality teams to address safety findings, deviations, and corrective and preventive actions (CAPAs).
• Collaborate closely with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, and Medical Writing.
• Support the development of the Integrated Summary of Safety (ISS), and the safety-related components of the New Drug Applications (NDA)/Biologics License Application (BLA), and Marketing Authorization Applications (MAA), in compliance with global regulatory standards.
• Review safety content of scientific publications such as posters, abstracts, and manuscripts.