Associate Medical Director, Drug Safety And Pharmacovigilance (pv)

Nuvalent

Remote, US
Base: $210,000 - $235,000 usd; bonus/equity: not s...
Remote
4+ years drug safety experience
Medical degree (md) preferred
Icsr medical assessment expertise
Nuvalent is seeking an Associate Medical Director for Drug Safety and Pharmacovigilance to provide medical assessments of safety reports and safety data interpretation. The role involves collaboration with safety teams and requires a strong background in drug safety regulations and practices

Job Summary

  • The role involves providing medical expertise in the assessment of Individual Case Safety Reports and interpreting safety data from clinical trials and other sources.
  • Candidates will contribute to the generation of aggregate safety reports such as DSURs and PSURs while ensuring compliance with US and EU regulatory requirements.
  • Nuvalent offers a competitive salary range of $210,000 to $235,000 USD along with comprehensive benefits including medical, dental, vision, and 401(k) plans.

Matching Summary

Match Score: 85

Nuvalent is seeking an Associate Medical Director for Drug Safety and Pharmacovigilance to provide medical assessments of safety reports and safety data interpretation. The role involves collaboration with safety teams and requires a strong background in drug safety regulations and practices.

Salary

Base: $210,000 - $235,000 USD; Bonus/Equity: Not specified; Benefits: Medical, dental, vision, 401(k), paid time off

Skills & Requirements

Must-have

  • 4+ years Drug Safety experience
  • Medical Degree (MD) preferred
  • ICSR medical assessment expertise
  • US and EU drug safety regulations knowledge
  • Aggregate report generation (DSUR/PSUR)
  • Clinical trial safety monitoring

Nice-to-have

  • Strong cross-functional collaboration skills
  • Experience with IND/NDA submissions
  • Regulatory authority negotiation experience
  • Risk Management Plan development
  • Excellent project management capabilities

Key Requirements

  • 8+ years industry experience required
  • Healthcare degree or MD from recognized school
  • Proficiency with MedDRA coding and SMQs
  • Experience with Reference Safety Information updates
  • Knowledge of CIOMS and ICH guidelines

Work Rights

Not specified

Tailored Resume

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