The case processing workflow in pharmacovigilance involves a series of steps and activities to manage and analyze individual cases of adverse drug reactions (ADRs) and other drug-related problems. While specific processes may vary depending on the pharmacovigilance system and organization, here is a generalized overview of the case processing workflow

1. CASE PROCESSING
WORK FLOW

2. RECEIPT OF CASE
TRIAGE
DATA ENTRY
QC REVIEW
MEDICAL REVIEW
REPORTING
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3. RECEIPT OF CASE
IVRS
IWRS

4. TRIAGE
TRIAGE
Seriousness
Expectedness Relatedness
It is the assessment, classification and
prioritization of the information received
according to regulatory ,Scientific and
Medical criteria

5. DATA ENTRY
Source
documents
Reporter
information
Patient
information
Medical
history
Laboratory
details
Family and
surgical
history
Clinical
course
Treatment
DATA BASE

6. QC REVIEW
Completeness and accuracy of cases
Suspected Unexpected Serious Adverse
Reaction
If any discrepancies , queries sent to the
reporter and data is updated in the case
Contacting the reporter via mail, phone

7. MEDICAL REVIEW
Confirming event
coding,
seriousness,
labelling and
causality
assessment

8. REPORTING
Safety
information
Regulatory bodies
case

9. BY
Jagillapuram Anusha
anushajagillapuram19@gmail.com
ID: 0122/001