Apogee Therapeutics - Medical Director Pharmacovigilance
Upload My Resume
Drop here or click to browse · Tap to choose · PDF, DOCX, DOC, RTF, TXT
Requirements
• 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.
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.
Benefits
• A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless • Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly • Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits • We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave • Commitment to growing you professionally and providing access to resources to further your development • Apogee offers regular all team, in-person meetings to build relationships and problem solve • E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.
Similar Jobs
No credit card. Takes 10 seconds.