Medical Director Pharmacovigilance, Rare Disease & Pdt

Takeda Development Center Americas, Inc.

Cambridge, MA, US
$222,600 - $381,600 py
Fully remote
Global safety lead responsibilities
Benefit-risk assessment
Signal detection and evaluation
Serve as Global Safety Lead and company-wide patient safety expert for assigned products, accountable for safety strategy and deliverables

Job Summary

  • Serve as Global Safety Lead and company-wide patient safety expert for assigned products, accountable for safety strategy and deliverables.
  • Lead Safety Teams and represent the cross-functional program team as a product safety profile and risk mitigation expert.
  • Provide patient safety input to clinical development programs and collaborate with various functional areas on safety issues.

Matching Summary

Serve as Global Safety Lead and company-wide patient safety expert for assigned products, accountable for safety strategy and deliverables.

Salary

$222,600 - $381,600 per year

Skills & Requirements

Must-have

  • Global Safety Lead responsibilities
  • Benefit-risk assessment
  • Signal detection and evaluation
  • Regulatory agency interactions
  • Company Core Data Sheet updates

Nice-to-have

  • Cross-functional collaboration
  • Medical interpretation and authorship
  • Patient safety input to development

Key Requirements

  • Doctor of Medicine (M.D.)
  • 5 years of related experience
  • Oracle Empirica utilization
  • MedDRA and WHO DD dictionary coding
  • Risk management plan development

Work Rights

Not specified

Tailored Resume

Cover Letter