Vice President, Drug Safety, Pharmacovigilance

Job Description: • Authority and accountability to develop, organize, manage and maintain a highly compliant PV system for Immunovant • Medical expert accountable for overall DSPV strategy and all deliverables of the DSPV function, including responsibilities for pharmacovigilance-related documents (e.g., DSUR) as well as safety sections of key documents (e.g., IBs, RSI, ICFs, study protocols, CSRs) and other applicable activities (IND/CTA, requests for information, regulatory responses) • Strategic decision maker accountable for providing medical and scientific expertise for product safety and risk assessments at all stages of product lifecycle • Responsible for oversight of the DSPV department, including building and managing a team of DSPV professionals (operations and safety science) to execute the development strategy and support registrational/post-marketing activities in a compliant and collaborative environment, in accordance with long-term strategic goals • Serves as lead safety representative in regulatory interactions and interactions with internal governance frameworks • 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 • Responsible for leading relevant Safety committees and teams • Oversee drug safety and pharmacovigilance activities conducted in partnership with external business partners or outsourced to vendors and contract research organizations • Ensure ongoing audit and inspection readiness of the DSPV function. • Responsible for department planning and forecasting efforts in relation to resources and overall management of PV budget. Requirements: • MD or equivalent degree; additional training/experience with rare diseases is preferred • 12 + years of relevant industry experience in biotech and/or pharmaceutical settings with significant time spent in senior leadership roles, including 5+ years of direct experience in Drug Safety and Pharmacovigilance (development and commercial stage) • Oversight experience of global medical safety activities, operations, and risk management strategies in pre and post marketing environments • Extensive knowledge of regulatory and compliance requirements governing drug safety and pharmacovigilance, as well as an overall understanding and knowledge of BLA global filing requirements • Proven prior experience with guiding a Drug Safety and Pharmacovigilance team through BLA and commercialization • Experience in building out DSPV marketed product infrastructure • Demonstrated thorough 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. Benefits: • Comprehensive medical, dental, vision insurance • 401k plan • Unlimited paid time off • Parental leave