Process Every Adverse Event. Detect Every Safety Signal.
Zabrizon's AI pharmacovigilance platform automates ICSR intake, processing, MedDRA coding, and regulatory submission — while continuously monitoring safety databases for emerging signals across your entire product portfolio.
Pharmacovigilance AI Capabilities
End-to-end drug safety automation from case intake through signal management.
Automated ICSR Intake & Processing
AI-powered case intake from all spontaneous sources — literature, social media, call centres, and direct patient reporting — with automated triage, duplicate detection, and E2B(R3) formatting.
- Multi-source ICSR intake: email, web, fax, and structured feeds
- Automatic duplicate detection and case merging
- Seriousness, expectedness, and causality pre-assessment
- E2B(R3) XML generation for FDA, EMA, and PMDA submission
AI MedDRA Coding & Medical Writing
NLP-powered MedDRA coding of adverse event narratives with 99.4% accuracy — eliminating the bottleneck of manual medical coding and ensuring consistent terminology.
- AI MedDRA PT/HLT/SOC coding from free-text narratives
- WHO Drug Dictionary coding for concomitant medications
- Narrative auto-generation from structured ICSR data
- Coding consistency review and outlier flagging
Signal Detection & Risk Management
Continuous statistical signal detection across your product safety database and public sources — with automated disproportionality analysis and signal prioritisation.
- PRR, ROR, and EBGM disproportionality analysis
- Literature monitoring across PubMed, Embase, and WHO feeds
- Social media signal harvesting and classification
- Signal management workflow: detection, validation, evaluation
PSUR / PBRER & Aggregate Report Automation
AI-assisted preparation of periodic safety update reports with automated data extraction, line listing generation, and regulatory narrative drafting.
- Automated ICSR line listings by product, indication, and AE
- Cumulative exposure data integration and tabulation
- PSUR/PBRER narrative drafting from structured data
- Submission-ready formatting for ICH E2C requirements
Global PV Regulatory Compliance
Supports pharmacovigilance obligations across all major health authority jurisdictions.
Ready to Transform Your Pharmacovigilance Operations?
See how Zabrizon's AI processes ICSRs 10× faster and detects safety signals before they become regulatory findings.
Explore All Life Sciences Solutions