Medical Director Pharmacovigilance

Role Overview

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.

What You Will Do

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.

Why It Might Be a Fit

This is a high-impact role where your expertise directly influences both regulatory success and patient outcomes. You will contribute to lifecycle management and long-term safety strategy for innovative therapies.

Requirements

• 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