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
• 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