💊 Pharma & Life Sciences · C4 Architecture · Pro
Pharmacovigilance Safety System Architecture
A drug safety platform that collects adverse event reports, codes them, detects signals and submits reports to regulators.
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Drawing diagram…
What this diagram shows
- Reports arrive from call centres, web forms and literature
- MedDRA coding and duplicate checks happen before assessment
- Expedited reports go to regulators electronically (E2B)
Prompt used
Pharmacovigilance architecture: adverse event reports come from patients and doctors via web forms and the medical information call centre, and from literature screening. An intake service de-duplicates cases; safety physicians code and assess them in the safety database (MedDRA coding, causality). A signal detection service runs disproportionality analysis. A regulatory submission gateway sends E2B(R3) reports to regulators.
Mermaid code
C4Container
title Pharmacovigilance Platform
Person(reporter, "Patient / Doctor", "Reports side effects")
Person(physician, "Safety Physician", "Assesses cases")
System_Ext(reg, "Regulators", "E2B(R3) gateways")
System_Ext(lit, "Literature Databases", "Published case reports")
System_Boundary(pv, "Safety Platform") {
Container(form, "Reporting Portal", "React", "Adverse event forms")
Container(intake, "Case Intake", "Java", "De-duplication and triage")
Container(safety, "Safety Database", "Java", "Coding and assessment")
Container(signal, "Signal Detection", "Python", "Disproportionality analysis")
Container(sub, "Submission Gateway", "Java", "E2B(R3) reports")
ContainerDb(db, "Case Store", "Oracle", "Cases and narratives")
}
Rel(reporter, form, "Submits report")
Rel(form, intake, "New case")
Rel(lit, intake, "Literature cases")
Rel(intake, safety, "Valid cases")
Rel(physician, safety, "Codes and assesses")
Rel(safety, db, "Stores")
Rel(safety, signal, "Case data")
Rel(safety, sub, "Expedited reports")
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