One platform for the full safety lifecycle
PVgenix is a complete pharmacovigilance case-management ecosystem covering the full safety lifecycle — from multi-channel case intake to regulatory submission, signal detection, aggregate reporting, and quality management.
One connected case record, every stage of the loop
Cases move from intake through triage, data entry, quality review, and submission — then feed surveillance and quality management, which loop back into safety decisions. Duplicate detection, follow-up tracking, versioning, and a full audit trail run at every step, across both clinical-trial and post-marketing sources.
The full capability set, across the lifecycle
Spanning the pharmacovigilance lifecycle — from multi-channel intake and AI-assisted extraction through submission, signal detection, aggregate reporting, and quality management.
Multi-channel case intake
Email, messaging and social channels, a web reporter portal, and file-based and API-based intake, with configurable forms per tenant.
AI-powered intake & extraction
Automated extraction from unstructured sources, domain-segmented extraction, AI-assisted narrative generation, and confidence scoring.
Case lifecycle management
Intake-to-submission workflow with duplicate detection, follow-up tracking, versioning, and workflow state management.
Case assessment
Seriousness and severity logic, causality and expectedness assessment, reference safety information management, and risk-based prioritization.
Clinical trial safety
SUSAR identification and expedited handling, blinding / unblinding workflow, and study and protocol configuration.
Coding & terminology
MedDRA and WHO Drug Dictionary management with admin-controlled version control, auto-coding, and manual override.
Regulatory submission & exchange
Regulatory clock and rules engine, E2B(R2) / E2B(R3) generation, CIOMS I and MedWatch outputs, and a built-in AS2 gateway.
Literature monitoring
Scheduled searches, automated screening, AI-assisted ICSR identification with reviewer confirmation, and article-to-case workflow.
Signal detection
PRR, ROR, BCPNN/IC, and EBGM disproportionality methods, masking detection, configurable thresholds, and lifecycle management.
Aggregate reporting
DSUR and PBRER / PSUR support, line listings, summary tabulations, and data reuse across reporting outputs.
Risk management
RMP / REMS support, signal-to-action linkage, and risk-minimization measure tracking across the product lifecycle.
Quality management (QMS)
Integrated CAPA, deviation, and change-control tracking with quality review workflows and inspection support.
This describes the platform's overall capability set, not a fixed shipped feature list; scope is defined per client agreement.
Map PVgenix to your safety operations
Request a demo to see how the lifecycle capabilities fit your intake channels, reporting obligations, and review workflows.