Vice President, Drug Safety and Pharmacovigilance (DSPV)

The Role:

The Vice President of Drug Safety and Pharmacovigilance (VP, DSPV) will serve as the global leader for Immunovant product safety and report to the Chief Operating Officer. The individual will provide strategic vision and operational oversight across all aspects of drug safety while ensuring regulatory compliance globally.

The VP, DSPV will lead all pre- and post-marketing safety, PV and risk management activities. The incumbent in this position must effectively interface cross-functionally at all levels in the organization as well as with external regulatory authorities. The VP, DSPV oversees and is responsible for the integration of pre-and post-marketing safety surveillance with Clinical Development and Medical Affairs activities and for ensuring an integrated and proactive approach to risk management. The VP, DSPV is also responsible for managing the organizational planning, budget and operations of the department.

Key Responsibilities: 

• 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

Work Environment:

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• Domestic or international travel is required (10-20%)