Safety Reporting Specialist
Core
Receive, prepare, and submit expedited and periodic safety reports to applicable parties while tracking submissions and maintaining regulatory compliance.
Role type
Associate safety reporting specialist
Builds
Regulatory submission files and filing processes for clinical research projects
Domain
Clinical research / Pharmaceutical safety reporting
Required skills
Medical terminology, Microsoft Office, safety database functionality, global safety reporting requirements (FDA), organizational skills, attention to detail
Preferred skills
Project management support, liaising with teams, ad hoc administrative support
Technologies
Microsoft Office, safety databases
Responsibilities
Receive, prepare, and submit safety reports; Track submission timelines and alert managers to issues; Maintain repositories and contact information; Prepare and archive regulatory submission files; Assist in collating project metrics
Seniority
Junior, 0-2 years experience