Director, Drug Safety & Pharmacovigilance Scientist
Dyne Therapeutics
This director-level position leads drug safety and pharmacovigilance functions for a neuromuscular disease-focused biotech company. The role encompasses strategic oversight of safety surveillance, signal detection, benefit-risk assessment, and risk management across clinical development programs. Based in Waltham, MA, this scientist will provide scientific leadership for safety profile characterization and communication.
Responsibilities
- Lead safety surveillance, signal detection, and benefit-risk evaluation across development programs
- Develop and implement risk management strategies and pharmacovigilance procedures
- Characterize and communicate safety profiles of investigational therapies
- Collaborate with Clinical Development, Regulatory Affairs, and Medical Affairs on safety strategy
- Ensure pharmacovigilance compliance with global regulations and company standards
Requirements
- Advanced degree in life sciences or pharmacy with pharmacovigilance expertise
- Experience with safety surveillance and signal detection methodologies
- Knowledge of global pharmacovigilance regulations and compliance requirements
- Demonstrated scientific leadership in benefit-risk assessment and evaluation
- Experience contributing to regulatory safety strategies and submissions
- Strong cross-functional collaboration skills across clinical and regulatory teams
Vacancy posted a month ago
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