Pharmacovigilance and Adverse Event Reporting

Start of the Workflow/Process.

Create a new entry in the Adverse Event Data Model to capture initial intake details.

Retrieve existing contact details from the Reporter Data Model using the provided identifier.

Update the current Case entry with updated seriousness criteria based on medical assessment.

Calculate the submission deadline by adding 7 or 15 days to the 'Date of Receipt' based on seriousness.

Create a task for a Medical Doctor to perform a causality assessment of the event.

Verify presence of 4 minimum criteria: Patient, Reporter, Event, and Product.

Get existing safety data from the Product Data Model to check for known signals.

Sum the total number of new Adverse Event entries created in the last 7 days for trend analysis.

Create a task for the QA specialist to verify the accuracy of the coded MedDRA terms.

Send an automated email to the relevant Health Authority (e.g., FDA/EMA) with the case summary.

Send an urgent email alert to the Safety Physician if a 'Serious' event is identified.

Create a standardized regulatory-compliant report formatted for electronic submission.

Update the status of the Case entry to 'Closed' and timestamp the closure date.

Create a follow-up task if the initial case entry is missing critical clinical information.

Create a monthly summary report aggregating all processed cases for the Safety Management Committee.

End of the Workflow/Process.