Medical Director – Pharmacovigilance

This is a fully remote position, open to applicants in United States.

📋 Description

• Detect emerging safety signals and ensure proper escalation through established internal safety governance pathways.

• Assist in the formulation and implementation of pharmacovigilance strategies for Apogee's clinical programs at various developmental stages.

• Conduct ongoing benefit–risk assessments that factor in disease severity, unmet medical needs, and new clinical data.

• Collaborate with Regulatory Affairs to craft responses to any inquiries from safety-related regulatory agencies.

• Guarantee high-quality MedDRA coding, accurate event characterization, and comprehensive safety narratives.

• Lead the preparation and review of Development Safety Update Reports (DSURs), Investigator’s Brochures (IBs), safety sections of protocols, informed consent forms (ICFs), and clinical study reports.

• Offer safety insights for regulatory submissions (INDs/CTAs), protocol amendments, and replies to health authority inquiries.

• Work in tandem 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 teams.

• Assist in the development of the Integrated Summary of Safety (ISS), as well as the safety-related components of New Drug Applications (NDA)/Biologics License Application (BLA), and Marketing Authorization Applications (MAA), in accordance with global regulatory standards.

• Evaluate safety content in scientific publications such as posters, abstracts, and manuscripts.

⛳️ Requirements

• A medical degree (MD) is mandatory.

• At least 8 years of pharmacovigilance experience in the biopharmaceutical sector.

• In-depth knowledge of global regulatory requirements (FDA, EMA, MHRA, PMDA, ICH).

• Experience with biologics and medications for immunology and inflammation (I&I) conditions, including dermatological and respiratory indications, is advantageous.

• Experience in late-stage development and regulatory submissions.

• Alignment with Apogee's C.O.R.E. values (Caring, Original, Resilient, and Egoless).

• Position may require up to 20% travel, including mandatory in-person attendance at All Hands meetings typically held biannually.

🏝️ Benefits

• A vibrant culture rooted in our C.O.R.E. values: Caring, Original, Resilient, and Egoless.

• An opportunity to thrive in a fast-paced, dynamic environment where you can influence the culture and organization, wear multiple hats, and learn rapidly.

• Competitive compensation and benefits package, including base salary, performance bonuses, equity grant opportunities, and health, welfare & retirement benefits.

• Generous time off policy that includes three weeks of PTO, two company-wide one-week shutdowns per year, and dedicated paid sick leave.

• Commitment to your professional growth with access to resources for further development.

• Regular in-person team meetings to foster relationships and address challenges.