Job Description
The Data Officer is responsible for the accurate, timely, and compliant management of vigilance data. This includes safety and administrative data handling, traceability, and integration into internal, client, and regulatory systems.
Responsibilities:
Data Management
Manage generic or client‑specific vigilance email inboxes Register initial vigilance cases in internal tracking tools Perform duplicate searches in client or PLG safety databases Conduct initial case triage and data entry (including MedDRA coding and narrative writing) Prepare acknowledgements and follow‑up request communications Perform case follow‑up via phone or email Detect and document vigilance cases Maintain and update internal tracking tools and client files Regulatory Submissions
Submit clinical and post‑marketing cases to Competent Authorities, Ethics Committees, Part...