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Vice President, Drug Safety and Pharmacovigilance (DSPV)

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Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases.

The Role:

The Vice President of Drug Safety and Pharmacovigilance (DSPV) will report to the Chief Medical Officer.  The individual will be responsible for providing oversight and management of all activities pertaining to Immunovant’s product safety and pharmacovigilance in clinical development and post-marketing surveillance.

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 & CP 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:

  • 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)

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

Work Environment:

  • Dynamic, interactive, fast-paced, and entrepreneurial environment.
  • Remote-based; will have access to Immunovant’s NYC/NC offices.
  • Domestic and international travel required (~10%).

 

Salary range for posting

$400,000 - $420,000 USD

Compensation is based on a number of factors, including market location, and may vary depending on job-related knowledge, skills, and experience. Equity and other forms of compensation may be provided as part of a total compensation package, in addition to a full range of medical, dental, vision, 401k, and other benefits, including unlimited paid time off and parental leave.

 

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