Senior Safety Reporting Coordinator
Core
Administrative safety support for the Pharmacovigilance department, focusing on submissions, tracking, filing, and archiving of expedited and periodic safety reports.
Role type
Senior Safety Reporting Coordinator
Builds
Safety report submissions and archives for pharmaceutical and biotech clients
Domain
Life Sciences / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Safety report submission and filing, complex issue resolution, team guidance and mentorship, procedure updates, training material creation, system data extraction and collation, contact list maintenance, audit support, file room management, client file coordination
Preferred skills
None stated
Technologies
Clinical Trial Management System, Microsoft Office (Word, Excel, PowerPoint, Access)
Responsibilities
Submit safety reports and manage electronic/paper filing; resolve complex submission issues; assist in receipt and preparation of submissions; provide direction to team members on administrative tasks; extract and collate reporting information; train department staff on safety reporting processes; support on-site audits; coordinate study files and inventories for clients
Seniority
Senior, hands-on IC with team leadership
