Overview In this role you lead safety surveillance and risk management for Dyne's development programs, shaping pharmacovigilance strategy and regulatory safety submissions. You collaborate across Clinical Development, Regulatory, Medical Affairs, and Quality to ensure compliant, scientifically rigorous safety oversight. You will translate complex safety data into actionable insights that support program decisions and patient safety. This is a leadership role that drives continuous improvement in PV processes in a fast-paced biotech setting.
Responsibilities- Lead safety surveillance and signal detection across development programs
- Develop risk management plans and safety monitoring strategies
- Author or contribute to DSURs, PSURs/PBRERs, and regulatory safety responses
- Review ICSRs, MedDRA coding, and causality assessments
- Prepare safety data and risk management recommendations for cross-functional teams
- Maintain inspection-ready PV documentation and processes
- Partner with cross-functional teams and external vendors for safety oversight
- Contribute to safety governance and program strategy across the organization
Key requirements- 10+ years in pharmacovigilance, drug safety, or related biotech/pharma industry experience
- Expertise in safety surveillance, signal detection, benefit-risk assessment, and risk management
- Experience authoring/contributing to DSURs, PSURs/PBRERs, and regulatory safety sections
- Deep knowledge of FDA, EMA, ICH, GVP, GCP, and safety reporting requirements
- Proficiency with MedDRA, safety databases, ICSR workflows, and safety management plans
- Strong analytical, scientific writing, presentation, and project management skills
- Ability to influence stakeholders in a matrixed organization
- Experience in rare disease or neuromuscular disease is a plus
- strong communication and collaboration
- strategic thinking with scientific judgment
- attention to detail and accountability
- safety surveillance and signal detection
- DSURs/PSURs/PBRERs
- ICSR review and MedDRA coding
