Medical Director Pharmacovigilance

Medical Director Pharmacovigilance

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:

• 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