Medical Director – Pharmacovigilance

Apogee Therapeutics

Medical Director managing pharmacovigilance in clinical development for biopharmaceutical company. Ensuring high-quality data generation for safety and efficacy of products in development.

Posted 6/1/2026full-timeRemote • 🇺🇸 United StatesLead💰 $285,000 - $330,000 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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

Benefits

Comp & perks

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

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Applicant Tracking System Keywords

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Hard Skills & Tools

pharmacovigilanceMedDRA codingbenefit-risk assessmentsafety narrativesregulatory submissionsclinical study reportsIntegrated Summary of SafetyNew Drug ApplicationsBiologics License ApplicationMarketing Authorization Applications

Soft Skills

collaborationleadershipcommunicationorganizational skillsattention to detailproblem-solvingadaptabilityteamworkstrategic thinkingresilience

Certifications

MD degree