Medical Director Pharmacovigilance

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Medical Director Pharmacovigilance in United States.

This role sits at the center of clinical safety strategy for a fast-evolving biotechnology organization developing novel biologics for high-need therapeutic areas. You will be responsible for overseeing pharmacovigilance activities across clinical programs, ensuring patient safety, regulatory compliance, and robust benefit–risk assessments throughout the product lifecycle. Acting as a key medical safety leader, you will collaborate across clinical development, regulatory affairs, and quality functions to shape safety strategy and support global submissions. The position plays a critical role in identifying safety signals, guiding regulatory responses, and ensuring high-quality safety documentation across all development stages. You will also contribute to lifecycle management and long-term safety strategy for innovative therapies. This is a high-impact role where your expertise directly influences both regulatory success and patient outcomes.

Accountabilities:

You will lead pharmacovigilance strategy and execution across clinical programs, ensuring the continuous monitoring, assessment, and communication of product safety. You will collaborate with cross-functional teams to maintain compliance with global regulatory standards and support successful submissions.

Identify, evaluate, and escalate emerging safety signals through internal governance and safety review processes
Develop and execute pharmacovigilance strategies across multiple stages of clinical development
Maintain and continuously update benefit–risk assessments using clinical, regulatory, and real-world data inputs
Lead preparation and review of key safety documents including DSURs, Investigator’s Brochures, protocols, ICFs, and clinical study reports
Provide safety input for regulatory submissions (INDs, CTAs, NDAs, BLAs, MAAs) and health authority responses
Ensure high-quality MedDRA coding, safety narratives, and consistent adverse event characterization
Partner with Regulatory Affairs, Clinical Development, Data Management, and Quality to address safety findings and CAPAs
Support integrated safety reporting, including ISS and lifecycle safety documentation

Requirements:

You bring deep expertise in pharmacovigilance within the biotech or pharmaceutical industry, with strong medical and regulatory understanding of global safety frameworks. You are experienced in late-stage development environments and comfortable operating across complex, cross-functional programs.

Medical Doctor (MD) degree required
8+ years of pharmacovigilance experience in the biopharmaceutical industry
Strong knowledge of global regulatory requirements (FDA, EMA, MHRA, PMDA, ICH guidelines)
Experience supporting biologics and/or immunology, dermatology, or respiratory programs is highly valued
Demonstrated experience in late-stage clinical development and regulatory submissions
Strong understanding of safety systems, signal detection, and benefit–risk evaluation
Excellent communication skills with the ability to translate complex safety data for regulatory and executive audiences
Strong cross-functional collaboration skills across clinical, regulatory, and medical teams

Benefits:

Competitive base salary aligned with experience and location
Annual performance-based bonus and equity opportunity
Comprehensive medical, dental, vision, life, and disability insurance
Generous paid time off including vacation, sick leave, and company-wide shutdown periods
Remote work flexibility with occasional travel for team and governance meetings
Professional development support and career growth opportunities
Inclusive, mission-driven culture focused on innovation and patient impact

How Jobgether works:

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Why Apply Through Jobgether?

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.

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Medical Director Pharmacovigilance

Requirements:

Benefits:

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