PV · ICSR · PSUR · Signal detection
Pharmacovigilance case records and periodic review.
Record cases and keep review evidence together.
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…
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.
What goes wrong today3 common problems
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.
Everything V5 does here5 capabilities
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.
How it works, step by step5 steps
PV in V5.
- Case opened. Multi-channel; dedup; MedDRA coded.
- Seriousness & Causality. Structured assessment with rationale.
- E2B(R3) submitted. Regulator-specific profile applied.
- Signals Surfaced. Disproportionality tracked; clocks started.
- PSUR / PBRER Assembled. Live data drives assembly.
What to look for when choosing
PV systems live on ICSR quality and E2B(R3) submission integrity. Criteria below matter more than pretty dashboards.
ICSR Intake Channels
Are consumer, HCP, literature, social and regulator channels covered? Multi-channel intake with de-duplication.
MedDRA Coding Assistance
Is MedDRA versioned and re-coding supported at version bump? MedDRA versioned with re-coding workflow.
E2B(R3) validation
Are messages validated to ICH E2B(R3) before submission? In-system E2B(R3) validation with regulator-specific profiles.
Signal Detection
Are disproportionality signals surfaced with rationale? PRR/ROR/EBGM signal surface with statutory clock tracking.
PSUR / PBRER Assembly
Are periodic reports assembly-supported from live data? Assembly derived from live ICSRs and signals.
V5 Compared with Other Approaches
PV approaches.
| capability | spreadsheet | legacy Qms | v5 |
|---|---|---|---|
| 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 |
Regulations this supportsYour quality team stays responsible for compliance
PV rules and V5's answer.
EU GVP Module VI
Intake, coding, reporting and follow-up per Module VI.
ICH E2B(R3)
Native message generation and validation.
21 CFR 314.80
US postmarketing reporting supported.
Standards Referenced
- 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
Common questions3 answers
- 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.