From a detected signal to a tracked risk measure
Most risk management breaks at the join: signals live in the safety database, the RMP lives in a document, and nobody can evidence which measure resulted from which finding. PVgenix keeps the safety concern register, the measures, and the evidence on the same audit trail as the cases and signals behind them.
Risk management is a loop, not a line
The step almost every operation can describe but few can evidence is step six. A signal gets evaluated and closed; a measure gets added to the plan; and two years later nobody can show which finding produced which measure, or whether the measure worked. Keeping the chain on one record is what makes that answerable.
Signal detected
Disproportionality, literature, or a case cluster surfaces something that needs evaluating.
PRR · ROR · EBGMEvaluated & dispositioned
A qualified assessor decides: no action, keep monitoring, further evaluation, or escalate to a risk.
human decisionRisk characterised
The finding becomes a safety concern on the register — identified risk, potential risk, or missing information.
safety concernMeasure selected
Routine or additional risk-minimisation measures are chosen — a regulatory and medical judgement, recorded with rationale.
human decisionImplemented & tracked
Status per measure, per market, with owners and review dates — so nothing is assumed to be live everywhere.
per marketEffectiveness reviewed
Indicators checked against the case data on a schedule; the outcome updates the plan, or raises a CAPA if the measure is not working.
closes the loopEvery concern linked to the measures that address it
An RMP is only as useful as the register behind it. Holding safety concerns in the three standard categories — with their measures, their markets, and their review status attached — turns the plan from a document that is rewritten each cycle into a view of something you already maintain.
| Category | Safety concern | Risk-minimisation measures | Status |
|---|---|---|---|
| Important identified risk | Hepatotoxicity | SmPC §4.4 warning · HCP educational material · monitoring guidance | Effectiveness review due |
| Important identified risk | Severe hypersensitivity | SmPC §4.3 contraindication · patient card | Implemented — 4 markets |
| Important potential risk | Embryo-foetal toxicity | Pregnancy prevention programme · controlled access | Implemented — 2 markets |
| Missing information | Use in severe renal impairment | Post-authorisation safety study commitment | Study ongoing |
| Missing information | Long-term exposure beyond 24 months | Registry · periodic review at each data lock point | Under monitoring |
Tied to the product information
Routine measures live in the authorised product information, so they move when the datasheet moves. Tracking them against the version-controlled reference safety information keeps the plan and the label in step.
Tracked individually, per market
Additional measures are where tracking usually slips: they are market-specific, they have owners and review dates, and their effectiveness has to be demonstrated rather than assumed.
Proving a measure actually worked
Adding a risk-minimisation measure is straightforward. Demonstrating that it changed anything is the part that gets questioned — and it is difficult when the indicators live in a spreadsheet and the case data lives somewhere else. Recording indicators against the measure, and querying them against the safety concern they address, makes the review a derivation rather than a reconstruction.
Defined when the measure is created, not invented at review time.
Review dates and owners recorded; escalation before the date passes.
A measure that is not working raises a CAPA rather than a note.
What risk management covers
The full capability set for risk management plan support, signal-to-action linkage and risk-minimisation measure tracking.
Risk management plan support
- Risk Management Plan (RMP) and REMS support aligned to your safety concern register
- Safety concerns maintained in the three standard categories — important identified risks, important potential risks, and missing information
- Each safety concern linked to the evidence that characterises it: cases, signals, literature, and aggregate report findings
- Version-controlled RMP documentation with retention aligned to regulatory requirements
- Post-authorisation study commitments tracked against the safety concern they address
Signal-to-action linkage
- A detected signal carries forward to the risk it characterises, rather than closing as a standalone assessment
- Signal disposition recorded with its outcome — no action, further evaluation, labelling change, or a new risk-minimisation measure
- The full chain is reconstructable: case → signal → evaluation → risk → measure → effectiveness review
- Configurable workflow states and review gates for signal escalation, matched to your SOPs
- Notifications and escalation when a linked commitment or review falls due
Risk-minimisation measure tracking
- Routine measures tracked against the product information they depend on — labelling, package leaflet, pack size, legal status
- Additional measures tracked individually — educational materials, controlled access programmes, pregnancy prevention programmes, patient cards, and registries
- Implementation status per measure, per market, so a measure required in one territory is not assumed everywhere
- Review dates and owners recorded, with alerts before a scheduled effectiveness review is due
- Measure history retained, so a superseded measure and the reason it changed remain part of the record
Effectiveness evidence & traceability
- Effectiveness indicators recorded per measure and reviewed on a schedule, rather than asserted at RMP update time
- Case and signal data queried against the safety concern a measure addresses, so the evidence is derived rather than assembled
- Findings routed into CAPA, deviation and change control where a measure is not working as intended
- Every create, read, update and delete captured with attribution and before/after values
- Reporting that supports the risk-management sections of periodic reports from the same underlying data
See the signal-to-action chain on your products
Book a demo to walk a signal through evaluation, risk characterisation, measure selection and an effectiveness review — on your safety concerns.