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← Dyne Therapeutics

Director, Drug Safety & Pharmacovigilance Scientist

Dyne Therapeutics
Location
Waltham, MA
Posted
1 month ago
Department
1210GL - Pharmacovigilance & Safety
What they actually want (must-haves)
  • Advanced degree in life sciences, health sciences, pharmacy, medicine, nursing, or a related discipline
  • 10+ years of relevant pharmacovigilance, drug safety, clinical development, or related biotechnology or pharmaceutical industry experience
  • Demonstrated expertise in safety surveillance, signal detection, signal evaluation, aggregate safety review, benefit-risk assessment, and risk management for clinical-stage development programs
  • Experience authoring or contributing to DSURs, PSURs/PBRERs, safety signal assessments, regulatory safety responses, and safety-related sections of clinical or regulatory documents
  • Deep knowledge of global pharmacovigilance regulations and guidance, including FDA, EMA, ICH, GVP, GCP, and applicable safety reporting requirements
  • Experience reviewing, analyzing, and interpreting clinical and safety data, including ICSRs, aggregate datasets, safety listings, tables, figures, and data visualizations
Nice to have
  • Experience in rare disease, neuromuscular disease, or clinical-stage biotechnology
What the job really is

The Director, Drug Safety & Pharmacovigilance Scientist at Dyne Therapeutics is responsible for leading safety surveillance and risk management activities for clinical development programs. This role involves analyzing safety data, contributing to regulatory submissions, and collaborating with various departments to ensure compliance and enhance pharmacovigilance processes. The position emphasizes strategic leadership in safety oversight and the communication of safety profiles for investigational therapies.

Things to weigh
  • No specific benefits listed in the posting
  • Salary range provided, but individual compensation may vary based on factors such as education and experience
  • Role involves significant cross-functional collaboration, which may require strong interpersonal skills
Job score2.8/5
Benefits1/5
Freshness4/5
Career value4/5
Role clarity5/5
Pay transparency0/5

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