Director, Drug Safety & Pharmacovigilance Scientist
Listed on 2026-09-13
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Healthcare
Medical Science, Clinical Research, Data Scientist
Company Overview
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations.
At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at , and follow us on X, Linked In and Facebook.
Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as well as preclinical programs for facioscapulohumeral muscular dystrophy (FSHD), Pompe disease and multiple DMD mutations.
At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at , and follow us on X, Linked In and Facebook.
The Director, Drug Safety & Pharmacovigilance Scientist provides strategic and scientific leadership for safety surveillance, signal detection, benefit-risk evaluation, and risk management activities across Dyne’s development programs. This role characterizes and communicates the safety profiles of investigational therapies, contributes to regulatory safety strategies and submissions, and ensures pharmacovigilance activities are conducted in compliance with applicable global regulations and company procedures. The Director collaborates across Clinical Development, Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management, Quality, and external partners to support proactive safety oversight and informed program decision-making.
The role applies expert scientific judgment to complex safety data, drives continuous improvement of pharmacovigilance processes, and contributes to a culture focused on patient safety, scientific excellence, and operational rigor.
This position is based in Waltham, MA.
Primary Responsibilities Include Safety Surveillance, Signal Detection & Risk Management- Conduct and lead safety surveillance activities for assigned clinical development programs, including ongoing review of aggregate safety data and identification of emerging safety trends.
- Lead signal detection, signal evaluation, risk classification, benefit-risk assessment, and risk management activities across the product lifecycle.
- Review, analyze, and interpret safety information from clinical studies, individual case safety reports (ICSRs), nonclinical studies, scientific literature, and other relevant sources.
- Support medical and scientific review of ICsRs, including evaluation of case narratives, MedDRA coding, causality assessments, expectedness determinations, company comments, and follow-up activities.
- Develop safety monitoring strategies and risk mitigation plans that support effective benefit-risk evaluation.
- Author and contribute to safety signal assessment reports, aggregate safety reports, and safety analyses, including DSURs, PSURs/PBRERs, and responses to health authority safety inquiries.
- Contribute to safety-related sections of clinical and regulatory documents, including protocols, informed consent forms, investigator brochures, reference safety information, clinical…
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