Director, Drug Safety & Pharmacovigilance Scientist
Dyne Therapeutics
August 20, 2026
On-site
Waltham, MA
Medical Affairs
Primary Responsibilities
- Conduct and lead safety surveillance activities for assigned clinical development programs; review aggregate safety data and identify emerging safety trends.
- Lead signal detection, signal evaluation, risk classification, benefit-risk assessment, and risk management across the product lifecycle.
- Review, analyze, and interpret safety information from clinical studies, ICSRs, nonclinical studies, scientific literature, and other sources.
- Support medical/scientific review of ICSRs (case narratives, MedDRA coding, causality, expectedness, company comments, and follow-up).
- Develop safety monitoring strategies and risk mitigation plans for effective benefit-risk evaluation.
- Author/contribute to safety signal assessment reports, aggregate safety reports, DSURs, PSURs/PBRERs, and responses to health authority safety inquiries.
- Contribute to safety sections of clinical/regulatory documents (protocols, consent forms, investigator brochures, safety reference info, CSRs, integrated safety summaries, briefing documents, regulatory submissions).
- Prepare/present safety analyses, recommendations, and risk management strategies to cross-functional teams.
- Maintain complete, accurate, inspection-ready pharmacovigilance documentation.
Qualifications / Required Skills
- Advanced degree in life/health sciences, pharmacy, medicine, nursing, or related field (MD/PhD/PharmD preferred).
- 10+ years of relevant pharmacovigilance/drug safety/clinical development experience.
- Expertise in safety surveillance, signal detection/evaluation, aggregate safety review, benefit-risk assessment, and risk management for clinical-stage programs.
- Experience with DSURs, PSURs/PBRERs, safety signal assessments, regulatory safety responses, and safety-related document sections.
- Deep knowledge of global pharmacovigilance regulations (FDA, EMA, ICH; GVP/GCP; safety reporting requirements).
- Experience reviewing and interpreting clinical/safety data (ICSRs and aggregate datasets, listings/tables/figures).
- Working knowledge of safety databases, MedDRA coding, ICSR workflows, safety management plans, and vendor oversight.
- Ability to apply scientific/medical judgment and communicate implications to stakeholders.
- Strong analytical/problem-solving, technical writing, presentation, and project management skills.
Preferred
- Experience in rare disease, neuromuscular disease, or clinical-stage biotechnology.
Location
- Waltham, MA.
Pay Range (base)
- $220,000 - $240,000 USD.
- Conduct and lead safety surveillance activities for assigned clinical development programs; review aggregate safety data and identify emerging safety trends.
- Lead signal detection, signal evaluation, risk classification, benefit-risk assessment, and risk management across the product lifecycle.
- Review, analyze, and interpret safety information from clinical studies, ICSRs, nonclinical studies, scientific literature, and other sources.
- Support medical/scientific review of ICSRs (case narratives, MedDRA coding, causality, expectedness, company comments, and follow-up).
- Develop safety monitoring strategies and risk mitigation plans for effective benefit-risk evaluation.
- Author/contribute to safety signal assessment reports, aggregate safety reports, DSURs, PSURs/PBRERs, and responses to health authority safety inquiries.
- Contribute to safety sections of clinical/regulatory documents (protocols, consent forms, investigator brochures, safety reference info, CSRs, integrated safety summaries, briefing documents, regulatory submissions).
- Prepare/present safety analyses, recommendations, and risk management strategies to cross-functional teams.
- Maintain complete, accurate, inspection-ready pharmacovigilance documentation.
Qualifications / Required Skills
- Advanced degree in life/health sciences, pharmacy, medicine, nursing, or related field (MD/PhD/PharmD preferred).
- 10+ years of relevant pharmacovigilance/drug safety/clinical development experience.
- Expertise in safety surveillance, signal detection/evaluation, aggregate safety review, benefit-risk assessment, and risk management for clinical-stage programs.
- Experience with DSURs, PSURs/PBRERs, safety signal assessments, regulatory safety responses, and safety-related document sections.
- Deep knowledge of global pharmacovigilance regulations (FDA, EMA, ICH; GVP/GCP; safety reporting requirements).
- Experience reviewing and interpreting clinical/safety data (ICSRs and aggregate datasets, listings/tables/figures).
- Working knowledge of safety databases, MedDRA coding, ICSR workflows, safety management plans, and vendor oversight.
- Ability to apply scientific/medical judgment and communicate implications to stakeholders.
- Strong analytical/problem-solving, technical writing, presentation, and project management skills.
Preferred
- Experience in rare disease, neuromuscular disease, or clinical-stage biotechnology.
Location
- Waltham, MA.
Pay Range (base)
- $220,000 - $240,000 USD.