PV Scientist
Edgewise Therapeutics · US
SafetyCompany career page
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Role summary
Edgewise Therapeutics seeks a Safety Scientist to conduct pharmacovigilance and safety assessments for cardiovascular drug candidates. The role involves collaborating with medical specialists on signal detection, regulatory reporting, and benefit-risk evaluations across clinical development programs.
What they're looking for
- Experience with safety assessments and pharmacovigilance activities in clinical development
- Knowledge of regulatory requirements for safety reporting and documentation
- Proficiency in compiling aggregate safety reports and clinical safety summaries
- Ability to collaborate effectively across clinical, regulatory, and medical affairs functions
- Experience managing serious adverse event data and signal detection processes
- Familiarity with contract research organizations and clinical trial operations
What you'll be doing
- Compile aggregate safety reports including DSURs, PBRERs, and PSURs with regulatory compliance
- Collaborate with safety physicians on signal detection and benefit-risk assessments
- Prepare safety documentation for regulatory submissions and labeling updates
- Oversee serious adverse event reconciliation between clinical and safety databases
- Support development of safety data tables and reporting plans for clinical trials
Privacy & handoff
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