Associate Director, Drug Safety And Pharmacovigilance Scientist

Nuvalent

Remote
$170,000 - $195,000 usd; not specified; comprehens...
Remote
Assess and interpret safety data
Generate safety reports (dsurs, paders, pbrers)
Contribute to signaling and safety surveillance
Nuvalent is seeking an Associate Director of Drug Safety and Pharmacovigilance Scientist to assess safety data and ensure compliance with regulatory requirements within the oncology drug development field. This remote role requires significant expertise in drug safety regulations and pharmacovigilance practices

Job Summary

  • The Associate Director, Drug Safety and Pharmacovigilance Scientist is responsible for assessing and interpreting safety data from multiple sources and providing interpretation and summaries of drug safety information.
  • Responsibilities include contributing to aggregate safety reports, signaling and safety surveillance processes, and serving as a medical resource for clinical trial documents and risk management plans.
  • Nuvalent is committed to fair and equitable compensation practices, offering a comprehensive benefit package including medical, dental, and vision insurance, and a 401(k) retirement savings plan.

Matching Summary

Match Score: 85

Nuvalent is seeking an Associate Director of Drug Safety and Pharmacovigilance Scientist to assess safety data and ensure compliance with regulatory requirements within the oncology drug development field. This remote role requires significant expertise in drug safety regulations and pharmacovigilance practices.

Salary

$170,000 - $195,000 USD; Not specified; Comprehensive benefit package

Skills & Requirements

Must-have

  • Assess and interpret safety data
  • Generate safety reports (DSURs, PADERs, PBRERs)
  • Contribute to signaling and safety surveillance
  • Medical resource for clinical trial documents
  • Develop Risk Management Plans (RMPs)
  • Collaborate cross-functionally with internal and external teams

Nice-to-have

  • Adapt visualization tools for safety surveillance
  • Influence multidisciplinary teams
  • Build relationships and collaborate across disciplines

Key Requirements

  • 4+ years' experience in Drug Safety / Pharmacovigilance
  • Degree in a medical or healthcare related discipline (MD, PharmD, RN, or PhD)
  • Excellent knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
  • Experience with medical drug safety assessments and surveillance
  • Experience with preparation of responses to Regulatory Authorities

Work Rights

Not specified

Tailored Resume

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