DRUG SAFETY SIGNAL DETECTION PROCESS

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[ ] Fetch Adverse Event Data: Retrieve all recent adverse event entries from the Pharmacovigilance Data Model for screening.
[ ] Aggregate Event Frequency: Calculate the total count and frequency of specific MedDRA terms across the retrieved dataset.
[ ] Calculate Disproportionality Index: Execute R-value or PRR (Proportional Reporting Ratio) calculations to identify statistical signals.
[ ] Create Potential Signal Record: Generate a new entry in the 'Signal Detection Log' for any case that exceeds the statistical threshold.
[ ] Assign Signal Validation Task: Create a task for a Drug Safety Physician to review the identified signal for clinical relevance.
[ ] Update Signal Status: Update the 'Signal Detection Log' entry to 'Under Review' once the validation task is assigned.
[ ] Fetch Safety Physician Assigned: Retrieve contact information and availability for the assigned Safety Physician from the User Data Model.
[ ] Notify Safety Committee: Send an email notification to the Safety Management Team regarding a newly detected potential signal.
[ ] Create Literature Review Task: Create a task for the Medical Writing team to perform a targeted literature search on the signal.
[ ] Retrieve Literature Findings: Pull data entries from the 'Literature Review' data model to assess evidence strength.
[ ] Determine Signal Strength Score: Calculate a weighted score based on literature evidence, clinical importance, and statistical significance.
[ ] Update Signal Assessment: Update the 'Signal Detection Log' with the final assessment decision (e.g., Validated, Non-Signal, or Follow-up Required).
[ ] Generate Signal Assessment Report: Create a formal PDF/Document report summarizing the signal detection process, data, and conclusion.
[ ] Notify Regulatory Affairs: Send an email to the Regulatory Affairs department if the signal is validated and requires potential labeling changes.
[ ] Clean up Transient Screening Data: Delete temporary screening calculation entries from the system to maintain data hygiene after process completion.

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