💊 Pharma & Life Sciences · Sequence
Adverse Drug Event Reporting
How a suspected side effect reported by a doctor or patient is captured, assessed and reported to the regulator on time (pharmacovigilance).
Drawing diagram…
What this diagram shows
- Reports come in from doctors, patients and the call centre
- Medical review decides seriousness and causality
- Serious cases go to the regulator within 15 days
Prompt used
Pharmacovigilance sequence: a doctor reports a suspected adverse drug reaction through the company portal, the safety database creates a case, a safety associate checks for duplicates and requests missing follow-up information, a medical reviewer assesses seriousness and causality, serious unexpected cases are submitted to the regulator (e.g. CDSCO / FDA) as an electronic ICSR within 15 days, and the case is included in periodic safety reports.
Mermaid code
sequenceDiagram
actor Dr as Doctor
participant Portal as Safety Portal
participant DB as Safety Database
participant SA as Safety Associate
participant MR as Medical Reviewer
participant Reg as Regulator
Dr->>Portal: Report suspected reaction
Portal->>DB: Create case (Day 0)
DB->>SA: New case
SA->>SA: Check duplicates
SA->>Dr: Request follow-up details
Dr-->>SA: Lab values, outcome
SA->>MR: Case ready for review
MR->>MR: Assess seriousness and causality
alt Serious and unexpected
MR->>Reg: E2B ICSR within 15 days
Reg-->>MR: Acknowledged
else Non-serious
MR->>DB: Include in periodic report
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