case processing
1.Case Intake & Triage
•Receive and review source documents (spontaneous, literature, clinical trial, etc.)
•Perform seriousness and validity check
2.Data Entry & Coding
•Enter data into safety database (Argus, ARISg, etc.)
•Code adverse events using MedDRA and products using WHO-DD
3.Narrative Writing
•Write or review medical narratives clearly and concisely
4.Case Quality Check
•Ensure accuracy, completeness, and regulatory compliance
5.Submission-Ready Case Finalization
•Prepare and submit cases to regulatory authorities (e.g., EudraVigilance, FDA)
6.Follow-Up Handling
•Manage follow-up requests and update cases accordingly