Medical Director Pharmacovigilance in United States at Jobgether

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.

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

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

• 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