Original listing text, shown exactly as published by the company.
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.
Ideal Candidate
- MD degree is required
- Minimum 8 years of pharmacovigilance experience in the biopharmaceutical industry
- Strong expertise in global regulatory requirements (FDA, EMA, MHRA, PMDA, ICH)
- Exposure to biologics, medications for I&I conditions including dermatology and respiratory indications a plus
- Experience in late-stage development and submissions
- Alignment with Apogee C.O.R.E. (Caring, Original, Resilient and Egoless) values
- Position requires up to 20% travel including mandatory in person attendance at All Hands meetings typically held twice per year, team meetings, conferences, etc.
The anticipated salary range for candidates for this role will be $285,000 to $330,000. 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.
