PHARMACOVIGILANCE AND ADVERSE EVENT REPORTING

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[ ] Initialize Adverse Event Case: Create a new entry in the Adverse Event Data Model to capture initial intake details.
[ ] Fetch Reporter Information: Retrieve existing contact details from the Reporter Data Model using the provided identifier.
[ ] Update Case Seriousness: Update the current Case entry with updated seriousness criteria based on medical assessment.
[ ] Calculate Regulatory Deadline: Calculate the submission deadline by adding 7 or 15 days to the 'Date of Receipt' based on seriousness.
[ ] Assign Medical Reviewer: Create a task for a Medical Doctor to perform a causality assessment of the event.
[ ] Mandatory Data Completeness Check: Verify presence of 4 minimum criteria: Patient, Reporter, Event, and Product.
[ ] Retrieve Product Safety Profile: Get existing safety data from the Product Data Model to check for known signals.
[ ] Aggregate Weekly AE Volume: Sum the total number of new Adverse Event entries created in the last 7 days for trend analysis.
[ ] Quality Control Review: Create a task for the QA specialist to verify the accuracy of the coded MedDRA terms.
[ ] Notify Regulatory Authorities: Send an automated email to the relevant Health Authority (e.g., FDA/EMA) with the case summary.
[ ] Alert Safety Physician: Send an urgent email alert to the Safety Physician if a 'Serious' event is identified.
[ ] Generate E2B XML Report: Create a standardized regulatory-compliant report formatted for electronic submission.
[ ] Close Adverse Event Case: Update the status of the Case entry to 'Closed' and timestamp the closure date.
[ ] Follow-up Task Generation: Create a follow-up task if the initial case entry is missing critical clinical information.
[ ] Monthly Signal Detection Report: Create a monthly summary report aggregating all processed cases for the Safety Management Committee.

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