Pharmacovigilance and Drug Safety Software Systems
ICSR case management, adverse event reporting, signal detection
Pharmacovigilance software (also called drug safety or PV systems) ingests, codes, assesses, and submits Individual Case Safety Reports (ICSRs) for marketed pharmaceutical products and clinical trials. These platforms handle the end-to-end workflow from initial intake through MedDRA coding, causality assessment, expedited and periodic reporting, and signal detection — the regulatory obligation that follows a drug from first-in-human through end-of-life.
Key Certifications
Core Features
What is Pharmacovigilance & Drug Safety?
A pharmacovigilance system centralizes adverse event data and automates regulatory reporting to global health authorities. Core capabilities include ICSR case intake (manual, literature, partner, patient portal), MedDRA and WHODrug coding, narrative authoring, medical review workflow, expedited E2B(R3) submission to FDA FAERS / EMA EudraVigilance / PMDA / NMPA, periodic aggregate reporting (PSUR/PBRER, DSUR, PADER), and signal detection over the cumulative case database. Modern platforms add AI-assisted intake triage, automated MedDRA coding suggestions, and literature monitoring.
Key Features to Consider
- ICSR case intake and processing (clinical, post-marketing, literature)
- MedDRA and WHODrug coding with auto-suggest
- E2B(R2) and E2B(R3) regulatory submission to FDA, EMA, PMDA, NMPA
- Expedited reporting workflows (15-day, 7-day) and PSUR/PBRER/DSUR generation
- Signal detection and management with disproportionality analysis
- Medical review and causality assessment workflow
- Literature surveillance and PubMed/Embase integration
- Risk Management Plan (RMP) authoring and tracking
Compliance Requirements
Pharmacovigilance systems must comply with ICH E2B(R3) for ICSR electronic transmission, EMA GVP (Good Pharmacovigilance Practices) modules I–XVI, FDA 21 CFR 314.80 (post-marketing) and 312.32 (IND safety), and country-specific requirements. Systems require complete audit trails per FDA 21 CFR Part 11 and EU Annex 11, validated state under GAMP 5, and demonstrable data integrity (ALCOA+). MedDRA licensing and WHODrug subscription are baseline requirements for coding.
Common Use Cases
- Processing post-marketing adverse event reports for marketed products
- Managing clinical trial SAE / SUSAR reporting and IND safety updates
- Generating periodic safety updates (PSUR, PBRER, DSUR, PADER)
- Running signal detection across cumulative safety database
- Submitting expedited ICSRs to FDA FAERS and EMA EudraVigilance
- Coordinating PV obligations across licensing partners and CROs
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