Position Overview:
The Senior Clinical Safety Specialist is responsible for managing adverse event reporting, device reporting, and safety deliverables for both investigational and marketed products. This role involves creating and implementing project-specific safety plans and overseeing the processing of events and complaints in line with study-specific operational plans.
This hybrid role requires a minimum of three days per week in the office in the Greater Boston area.
Key Responsibilities:
- Oversee adverse event processing, including report review, safety query management, and expedited reporting.
- Determine the type and level of processing required for adverse events.
- Draft study-specific safety documents and plans (e.g., safety plan, CEC/IMR Charter).
- Serve as a member of the clinical core team.
- Conduct Clinical Trial Safety Review meetings.
- Ensure adjudication and reconciliation of safety events are completed before data snapshots.
- Provide safety-related input to other study documents and processes as needed (e.g., protocol, CRF design).
- Manage functional deliverables to ensure study milestones are met on time.
- Handle additional projects, deliverables, and timelines to support activities within the clinical department.
