Medical Review Report | PharmaBharat Tools

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Medical Review Report | PharmaBharat Tools

Categories

Aggregate Reporting(35)

AI & ML in Pharmacovigilance(21)

Audit & Inspection Readiness(30)

Audits & Inspections(20)

Case Intake & Triage(42)

Case Processing & Data Entry(49)

India CDSCO & PvPI(20)

Data Privacy & Masking(21)

GVP & ICH Updates 2026(9)

Medical Review(26)

Autopsy Report Medical Review Clinical Significance Medical Review Report PV Physician Scientific Review Adverse Event of Special Interest(AESI)Benefit-Risk Assessment(B/R)Company Core Safety Information(CCSI)Clinical Overview Data Monitoring Committee(DMC)Drug Safety Committee(DSC)Drug Utilization Study(DUS)Investigator's Brochure(IB)IRB/EC Notification Product Labeling Medical Review Medically Confirmed Case Pharmacovigilance Physician Qualified Person for Pharmacovigilance(QPPV)Reference Safety Information(RSI)Safety Signal Safety Update Report(SUR)Safety Variation Summary of Product Characteristics(SmPC)Targeted Follow-up(TFU)

Quality Review(46)

Real-World Data & RWE(21)

Regulatory Harmonization(12)

Regulatory Reporting(83)

Risk Management(68)

Seriousness & Causality Assessment(34)

Signal Detection & Validation(43)

Signal Management(20)

Progress

0%

PV Medical ReviewMedical Review Report

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Clinical Significance PV Physician

Medical Review Report

Medical Review

Definition

Documented output of medical review (causality, seriousness, comment).

Example

Medical review: probable causality, serious, expedited.

Regulatory source

GVP VI

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