Vice President, Drug Safety and Pharmacovigilance

Summary

Join Immunovant, Inc., a clinical-stage immunology company, as their Vice President of Drug Safety and Pharmacovigilance (DSPV). Reporting to the Chief Medical Officer, you will oversee all aspects of product safety and pharmacovigilance across clinical development and post-marketing surveillance. Lead pre- and post-marketing safety, pharmacovigilance, and risk management activities, collaborating cross-functionally and with regulatory authorities. This role requires managing the department's operations, budget, and personnel. You will ensure compliance with FDA and ICH guidelines and maintain audit readiness. The position offers a remote-based work environment with occasional travel.

Requirements

• MD or equivalent degree; specialty training preferred
• 12 + years of relevant industry experience, including 5+ years of experience in Drug Safety and Pharmacovigilance
• 7 + years in leadership position including experience leading multidisciplinary teams
• Oversight experience of global medical safety activities, operations, and risk management strategies in pre and post marketing environments
• Experience with global regulatory filings
• Demonstrated knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments
• Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
• Ability to combine pharmacovigilance expertise with exceptional leadership (strategic thinking, people, and resource management )
• Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines with the ability to work independently and as part of a team
• Strong interpersonal skills including verbal and written communication
• Thorough knowledge of relevant FDA and International Conference on Harmonisation (ICH) guidelines, including Good Clinical Practices (GCP) guidelines

Responsibilities

• Manage all aspects of Drug Safety and Pharmacovigilance, including leadership of safety data review, signal detection, risk communication including safety information updates, and mitigation of potential risks
• Provide medical and drug safety expertise to enable decision-making based on ongoing risk-benefit assessment and clinical trial data interpretation
• Collaborate with appropriate clinical, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues including review of Investigator Brochures, development plans, INDs/CTAs, regulatory responses and serious adverse event handling and all other PV items, as appropriate
• Chair for the Safety Review Committee
• Oversee DSPV Operations team, supporting the recruitment, training and professional development of personnel
• Oversee drug safety and pharmacovigilance activities conducted in partnership with external business partners or outsourced to vendors and contract research organizations
• Ensure audit and inspection readiness of the function at all times
• Successfully plan and forecast for global resources and PV budget and partner with other groups on resource needs (e.g., medical organization for writing and statistical staffing; medical affairs for epidemiology project needs)

Benefits

• Full range of medical, dental, vision, 401k, and other benefits
• Unlimited paid time off
• Parental leave