Vice President, Drug Safety, Pharmacovigilance

Immunovant

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $400,000 - $425,000 per year

Job Level

Lead

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Drug SafetyPharmacovigilanceRisk ManagementClinical Trial Data InterpretationRegulatory ComplianceBLA Global FilingSafety ReportingOperations ManagementDSPV StrategyAudit and Inspection Readiness
Soft Skills
LeadershipStrategic ThinkingOrganizational SkillsCommunicationInterpersonal SkillsClinical JudgmentTeam ManagementPrioritizationCollaborationDecision-Making
Certifications
MD or equivalent degree