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Director, Drug Safety & Pharmacovigilance Scientist

Dyne Therapeutics · Waltham, MA

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Role summary

This director-level position leads drug safety and pharmacovigilance functions for a neuromuscular disease-focused biotech company. The role encompasses strategic oversight of safety surveillance, signal detection, benefit-risk assessment, and risk management across clinical development programs. Based in Waltham, MA, this scientist will provide scientific leadership for safety profile characterization and communication.

What they're looking for

  • Advanced degree in life sciences or pharmacy with pharmacovigilance expertise
  • Experience with safety surveillance and signal detection methodologies
  • Knowledge of global pharmacovigilance regulations and compliance requirements
  • Demonstrated scientific leadership in benefit-risk assessment and evaluation
  • Experience contributing to regulatory safety strategies and submissions
  • Strong cross-functional collaboration skills across clinical and regulatory teams

What you'll be doing

  • Lead safety surveillance, signal detection, and benefit-risk evaluation across development programs
  • Develop and implement risk management strategies and pharmacovigilance procedures
  • Characterize and communicate safety profiles of investigational therapies
  • Collaborate with Clinical Development, Regulatory Affairs, and Medical Affairs on safety strategy
  • Ensure pharmacovigilance compliance with global regulations and company standards

Privacy & handoff

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What RoleLantern checked

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RoleLantern checked active
RoleLantern checkedNeeds clarity
Date posted29 days ago
Last source check1 day ago
Salary listedNeeds clarity
Location clearClear
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