Director, Global Drug Safety & Pharmacovigilance Strategy

BioSpace; Waltham (MA); On-site; USD 220,000 - 240,000; Full time

Job summary

Dyne Therapeutics is seeking a Director, Drug Safety & Pharmacovigilance Scientist based in Waltham, MA to lead safety surveillance, signal detection, benefit‑risk evaluation, and risk management across development programs.

You will collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics and Quality to ensure regulatory compliance, safety signaling, and continuous improvement of pharmacovigilance processes, while maintaining inspection readiness.

Responsibilities

• Lead safety surveillance activities for clinical development programs, review safety data and identify emerging safety trends.
• Oversee signal detection, risk classification, and benefit-risk assessment across the product lifecycle.
• Prepare safety data, analyses, and risk management recommendations for cross-functional teams and governance committees.
• Maintain inspection-ready pharmacovigilance documentation and contribute to regulatory safety submissions.

Job description

Dyne Therapeutics is seeking a Director, Drug Safety & Pharmacovigilance Scientist based in Waltham, MA to lead safety surveillance, signal detection, benefit‑risk evaluation, and risk management across development programs.

You will collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics and Quality to ensure regulatory compliance, safety signaling, and continuous improvement of pharmacovigilance processes, while maintaining inspection readiness.