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Vice President, Drug Safety and Pharmacovigilance (DSPV)

3 weeks, 6 days ago
Anywhere
Full-time
Executive
Operations Manager
Operations
Apply Now
Immunovant

Immunovant

Pharmaceuticals
51-250
Founded 2018
$725M raised
View All Jobs 3

Description

  • Develop, organize, manage, and maintain a highly compliant pharmacovigilance system for the company.
  • Own overall drug safety and pharmacovigilance strategy and deliverables, including key safety documents and regulatory responses.
  • Provide medical and scientific expertise for product safety and risk assessments throughout the product lifecycle.
  • Lead and manage the DSPV team, including operations and safety science, to support development and commercial activities.
  • Serve as the lead safety representative in regulatory interactions and internal governance forums.
  • Provide drug safety expertise to support ongoing risk-benefit assessments and clinical trial data interpretation.
  • Collaborate with clinical, medical, quality, regulatory, and other cross-functional partners on safety and PV issues.
  • Lead relevant safety committees and teams.
  • Oversee pharmacovigilance activities performed with external partners, vendors, and CROs.
  • Ensure audit and inspection readiness and manage department planning, forecasting, and PV budget oversight.

Requirements

  • MD or equivalent degree.
  • Additional training or experience with rare diseases is preferred.
  • 12+ years of relevant industry experience in biotech and/or pharmaceutical settings.
  • Significant senior leadership experience, including 5+ years of direct experience in Drug Safety and Pharmacovigilance across development and commercial stages.
  • Experience overseeing global medical safety activities, operations, and risk management strategies in pre- and post-marketing environments.
  • Strong knowledge of regulatory and compliance requirements governing drug safety and pharmacovigilance.
  • Overall understanding of global BLA filing requirements.
  • Proven experience guiding a Drug Safety and Pharmacovigilance team through BLA and commercialization.
  • Experience building DSPV infrastructure for marketed products.
  • Thorough knowledge of FDA, EU, and ICH guidelines, initiatives, and regulations governing safety reporting and processing in clinical trial environments.
  • Excellent clinical judgment and ability to communicate complex clinical issues clearly and scientifically.
  • Strong leadership skills, including strategic thinking and people and resource management.
  • Excellent organizational skills and ability to prioritize and deliver results under aggressive timelines.
  • Ability to work independently and as part of a team.
  • Strong verbal and written communication skills.

Benefits

  • Remote-based work environment.
  • Salary range of $400,000 to $425,000 USD.
  • Equity may be provided as part of the total compensation package.
  • Medical, dental, and vision coverage.
  • 401(k) and other benefits.
  • Unlimited paid time off.
  • Parental leave.
  • Travel may be required at 10-20% for the role.

Interested in this position?

Apply directly on the company website

Apply Now

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