Pharmacovigilance software that closes the loop from case intake to signal.
V5 PV runs the case lifecycle: intake from any channel, MedDRA coding, seriousness and expectedness assessment, E2B(R3) submission to FAERS / EudraVigilance / MHRA, PSUR / PBRER assembly and signal detection — with the QPPV oversight dashboard live, not compiled.
What breaks without this.
Cases arrive in ten formats
Call centre, email, portal, HCP letter, literature — each with its own intake sheet and re-keying step, dropping E2B fields on the floor.
MedDRA and WHODrug coding is inconsistent
Two coders pick two different LLTs for the same verbatim — the aggregate data is unusable for signal detection.
PSUR is a three-month project every year
Data pulled from five systems, cleaned in Excel, drafted in Word — with the QPPV signing off on something they didn't produce.
Records-by-execution. Compliance, by design.
Unified case intake
Call centre, email parser, HCP portal, literature feed and regulator inbox all land in one triage queue with duplicate detection and E2B field auto-population.
MedDRA / WHODrug coding with QC
Auto-coding suggestions with confidence, coder QC, second-review workflow — dictionary versions locked per case and auto-upgraded on schedule.
E2B(R3) submission to every gateway
FAERS (FDA), EudraVigilance (EMA), MHRA, PMDA, Health Canada — with ACK1/2/3 monitoring and resubmission workflow.
PSUR / PBRER assembly
Templates aligned to ICH E2C(R2), populated from the case database, cumulative and interval tables auto-generated, QPPV signature captured.
Signal detection
Disproportionality (PRR, ROR, EBGM), triage, evaluation, action — with signal-to-decision timelines evidenced against GVP Module IX.
What to look for when you're buying.
PV systems live on ICSR quality and E2B(R3) submission integrity. Criteria below matter more than pretty dashboards.
ICSR intake channels
What it tests: Are consumer, HCP, literature, social and regulator channels covered?
Why it matters: Missed channels are missed cases.
V5: Multi-channel intake with de-duplication.
MedDRA coding assistance
What it tests: Is MedDRA versioned and re-coding supported at version bump?
Why it matters: MedDRA drift causes signal detection gaps.
V5: MedDRA versioned with re-coding workflow.
E2B(R3) validation
What it tests: Are messages validated to ICH E2B(R3) before submission?
Why it matters: Reject/resubmit consumes days.
V5: In-system E2B(R3) validation with regulator-specific profiles.
Signal detection
What it tests: Are disproportionality signals surfaced with rationale?
Why it matters: Statutory signal management timelines apply.
V5: PRR/ROR/EBGM signal surface with statutory clock tracking.
PSUR / PBRER assembly
What it tests: Are periodic reports assembly-supported from live data?
Why it matters: Manual assembly is where teams drown.
V5: Assembly derived from live ICSRs and signals.
Spreadsheet vs legacy QMS vs V5.
PV approaches.
| Capability | Spreadsheet | Legacy QMS | V5 Ultimate |
|---|---|---|---|
| Multi-channel intake | Email inbox | Manual | Native + dedup |
| MedDRA re-coding | None | Manual | Version-aware workflow |
| E2B(R3) validation | None | Add-on | In-box |
| Signal detection | None | Separate tool | Native |
The clauses, verbatim — and how V5 answers each.
PV rules and V5's answer.
Management and reporting of adverse reactions to medicinal products...
V5: Intake, coding, reporting and follow-up per Module VI.
Electronic transmission of individual case safety reports...
V5: Native message generation and validation.
Postmarketing reporting of adverse drug experiences.
V5: US postmarketing reporting supported.
Step by step on the floor.
PV in V5.
- 1Intake
Case opened
Multi-channel; dedup; MedDRA coded.
- 2Assess
Seriousness & causality
Structured assessment with rationale.
- 3Report
E2B(R3) submitted
Regulator-specific profile applied.
- 4Monitor
Signals surfaced
Disproportionality tracked; clocks started.
- 5Aggregate
PSUR / PBRER assembled
Live data drives assembly.
The math, with the assumptions visible.
PV ROI is timeliness and staff cost.
Report rejection rate
In-system validation.
PSUR assembly labour
Derived assembly.
Signal detection lag
Native detection.
PV teams typically redirect a full FTE to signal work within a quarter.
What changed on the floor.
Setting
A mid-size EU MAH with 3 products in monitoring.
Before
5% E2B rejection; PSURs took 8 weeks each.
After
Under 1% rejection; PSUR assembly under a week.
Proof points
- Case intake to E2B submission inside regulatory timelines
- MedDRA/WHODrug coding QC'd, not assumed
- PSUR assembled from live data — QPPV signs what the system produced
- GVP Module IX signal workflow evidenced end-to-end
Built to satisfy
- ICH E2B(R3) (electronic transmission of ICSRs)
- ICH E2C(R2) (PBRER)
- ICH E2D (post-approval safety data)
- ICH E2E (pharmacovigilance planning)
- EU GVP Modules I–XVI
- 21 CFR 314.80 / 600.80 (FDA post-marketing reporting)
- MHRA Good Pharmacovigilance Practice
Related on V5
Frequently asked questions
Does V5 replace Argus / ArisGlobal?+
For small and mid-size MAHs, yes — V5 PV covers ICSR, E2B(R3), PSUR and signal on one platform. Large MAHs typically run V5 alongside for affiliate intake, coding QC and QPPV oversight.
How is MedDRA licensing handled?+
Customer holds the MedDRA subscription; V5 consumes the dictionary and manages version upgrades per MSSO release schedule with impact analysis on coded cases.
Can V5 integrate with our clinical safety database?+
Yes — bi-directional E2B(R3) transfer with the clinical safety system, with reconciliation reports for cases that appear in both post-marketing and study contexts.
See V5 on your own line.
Free trial, no card. Live in 7 days with guided onboarding.