AI-assisted pharmacovigilance softwarefor CROs and small-to-mid pharma
Multi-channel intake, AI-assisted extraction and MedDRA coding, E2B(R3) submission, signal detection and aggregate reporting — fully hosted with zero client-side IT setup, and qualified people in control of every regulated decision.
Data Sources
Automatic Ingestion
AI Processing
Intelligent Analysis
Validation
Smart Classification
Data Output
Structured Export
Aligned with the world's regulatory authorities
PVgenix is built around the standards, formats, and reporting obligations of the major pharmacovigilance regulators worldwide. Teams operating from India can review the India deployment details.
ICH
Aligned with global ICH pharmacovigilance standards.
FDA
Built for stringent U.S. FDA safety reporting rules.
EMA
Compliant with EU drug safety and risk management.
MHRA
Meets UK post-Brexit drug safety regulations.
CDSCO
Supports India's ADR monitoring requirements.
One PV system, one case record
Eleven modules on one case record. Intake, AI-assisted extraction and coding, assessment, electronic submission over a built-in AS2 gateway, AI-assisted literature monitoring, signal detection and aggregate reporting — one system, one audit trail. Not separate tools stitched together, and not a base licence with the useful parts sold back to you as add-ons.
One case record, not a dozen disconnected tools
Nothing is re-keyed between systems and there is no spreadsheet in the middle. Every module reads and writes the same case, so a follow-up, a literature hit and a submission acknowledgement all land on one version-controlled record.
AI carries the volume: extraction from PDFs and emails, narrative drafting, literature screening, auto-coding. The judgement stays with your qualified people — causality, expectedness and seriousness sign-off never happen without a named reviewer.
AI speed with human-in-the-loop control
- Built-in AS2 gateway — no separate gateway licence
- E2B(R2) & E2B(R3) generation and validation
- FAERS/ESG, EudraVigilance and MHRA submission
- CIOMS I and MedWatch 3500A form outputs
- AI-assisted literature screening and article-to-case
- PRR, ROR, BCPNN/IC and EBGM signal statistics
- DSUR, PBRER/PSUR, line listings and tabulations
- Managed hosting, backups and audit logging
MedDRA and WHO Drug Dictionary licences are procured by you — PVgenix integrates the dictionaries and manages their versions, but does not resell the licences.
OnePV modules are switched on to your agreed scope — a substantial base is already built, and the rest is configured or built to your requirements. The map also covers quality management, reconciliation and document control, and it ships validation-ready with an IQ/OQ/PQ documentation package.
See the full platform overviewThe six modules your team works in every day
Zoom in on the modules from the map above: what each one actually does, what it produces, and where a qualified reviewer has to sign off before a case moves on.
Multi-channel intake with automated extraction and case creation — reviewed and approved by qualified people before a case proceeds.
Disproportionality methods (PRR, ROR, BCPNN/IC, EBGM), masking detection, and configurable thresholds across the signal lifecycle.
Scheduled searches with automated screening and AI-assisted ICSR identification — confirmed by a qualified reviewer.
Regulatory clock and rules engine, E2B(R2)/E2B(R3) generation, and a built-in AS2 gateway with submission-compliance tracking.
DSUR and PBRER/PSUR support, line listings, and summary tabulations — with data reuse across reporting outputs.
Integrated QMS with CAPA, deviation, and change-control tracking — tied to case processing and inspection support.
Beyond these six, the same case record drives ICSR case processing and risk management. See how the modules fit together on the full platform overview, or start with the pharmacovigilance software category page.
Built for the teams that carry the reporting obligation
The same platform, configured for how your operation is structured and what you are accountable for.
Equivalent core capability, modern delivery
Many existing safety systems run on older technology and cost models. PVgenix delivers the same regulated capability on current-generation, cloud-native technology — without the long cycles or heavy licensing. That covers full ICSR management and AI-assisted pharmacovigilance, with qualified people retaining every regulated decision.
Multi-month professional-services engagement
Guided onboarding in weeks, not quarters
Heavy per-seat licensing, locked into long terms
Transparent subscription that scales with you
On-prem servers maintained by your own IT team
Fully managed, cloud-native hosting by PVgenix
Scheduled, disruptive upgrade windows
Continuous delivery with zero downtime
Evidence gathered manually for every audit
GxP-aligned and audit-ready by design
Two deployment models,
one codebase.
Run PVgenix as a fully hosted multi-tenant, multi-client system or as a dedicated single-tenant deployment — both built from a single product codebase for complete feature consistency. The deployment and onboarding process sets out what each model involves.
models
codebase
for SaaS
Multi-tenant SaaS
Fully hosted and managed by PVgenix with logically isolated tenants, provisioned from the portal with no client-side IT setup.
Dedicated single-tenant
Isolated application and database per client, deployable in the client's preferred environment with full control over the hosting stack.
Surface real signals, not noise
Run quantitative disproportionality across the safety database, apply masking detection, and tune thresholds for each stage of the signal lifecycle — every flagged signal routed to a qualified assessor.
PRR, ROR, BCPNN/IC and EBGM computed continuously, with confidence intervals and case-count gating.
Identify where a high-frequency event hides emerging signals, and re-stratify automatically.
Set method-specific cut-offs per product, per lifecycle stage, with a full audit trail of every change.
One pipeline, every case in view
Track each ICSR from intake through submission in a single live console — every stage time-stamped, AI-assisted, and gated by qualified review, with operational metrics updating in real time.
See PVgenix on your own cases
Book a walkthrough of multi-channel intake, AI-assisted extraction, and the compliance documentation package.