Clinical Safety Project Assistant
Core
Support the Clinical Safety department by processing safety reports, managing correspondence with regulatory authorities, and maintaining safety documentation.
Role type
Junior Clinical Safety Project Assistant
Builds
Clinical safety reports, regulatory correspondence, and departmental documentation
Domain
Clinical Research / Clinical Safety
Deliverable
dashboards & analysis
Required skills
Safety report processing, Regulatory correspondence management, Document tracking, SOP compliance, Quality control reviews, Database/spreadsheet maintenance
Preferred skills
Basic research, Mentoring junior staff
Technologies
Microsoft Office
Responsibilities
Process safety reports and create safety notification letters; Track and fill correspondence with Regulatory Authorities and Ethics Committees; Prepare reports, presentations, and meeting minutes; Conduct quality control reviews of department documents; Maintain databases and spreadsheets for activity tracking.
Seniority
Entry-level, support role