ChecklistGuro Pharmacovigilance and Adverse Event Reporting
Streamline your drug safety monitoring with our specialized Pharmacovigilance and Adverse Event Reporting workflow. Ensure global regulatory compliance, accelerate signal detection, and master end-to-end case management with a standardized, audit-ready process designed to enhance patient safety and mitigate pharmaceutical risk.
Este modelo foi instalado 2 vezes.
Começar
Início do fluxo de trabalho/processo.
1. Initialize Adverse Event Case
Create a new entry in the Adverse Event Data Model to capture initial intake details.
2. Fetch Reporter Information
Retrieve existing contact details from the Reporter Data Model using the provided identifier.
3. Update Case Seriousness
Update the current Case entry with updated seriousness criteria based on medical assessment.
4. Calculate Regulatory Deadline
Calculate the submission deadline by adding 7 or 15 days to the 'Date of Receipt' based on seriousness.
5. Assign Medical Reviewer
Create a task for a Medical Doctor to perform a causality assessment of the event.
6. Mandatory Data Completeness Check
Verify presence of 4 minimum criteria: Patient, Reporter, Event, and Product.
7. Retrieve Product Safety Profile
Get existing safety data from the Product Data Model to check for known signals.
8. Aggregate Weekly AE Volume
Sum the total number of new Adverse Event entries created in the last 7 days for trend analysis.
9. Quality Control Review
Create a task for the QA specialist to verify the accuracy of the coded MedDRA terms.
10. Notify Regulatory Authorities
Send an automated email to the relevant Health Authority (e.g., FDA/EMA) with the case summary.
11. Alert Safety Physician
Send an urgent email alert to the Safety Physician if a 'Serious' event is identified.
12. Generate E2B XML Report
Create a standardized regulatory-compliant report formatted for electronic submission.
13. Close Adverse Event Case
Update the status of the Case entry to 'Closed' and timestamp the closure date.
14. Follow-up Task Generation
Create a follow-up task if the initial case entry is missing critical clinical information.
15. Monthly Signal Detection Report
Create a monthly summary report aggregating all processed cases for the Safety Management Committee.
Fim
Fim do fluxo de trabalho/processo.
Início do fluxo de trabalho/processo.
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.
Fim do fluxo de trabalho/processo.
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