VigiCore

Shared PV Workspace

OnePV Platform

A unified pharmacovigilance workspace for signal management, literature monitoring, PSMF readiness, and future PV operations.

MFA protected Tenant-aware Audit-ready Reviewer controlled

One Login. Multiple PV Apps.

Enter one controlled workspace, then choose the PV application you need

Your access is controlled by your organization, role, tenant, and enabled applications. Signal Automation, Literature Monitoring, and PSMF are available from this shared OnePV workspace. Access remains controlled by your organization, role, tenant, and enabled applications.

Shared OnePV sign-in Tenant-aware access Enabled applications only

Secure Access

Sign in to OnePV

Sign in once to access your enabled PV applications. Activity may be logged for audit, security, and inspection-readiness.

Enter the authenticator code for this sign-in session.

First sign-in requires a new password before MFA setup.

Set up MFA

Add this setup key to your authenticator app, then enter the generated code.

Reset password

Enter the reset code from the Cognito email and create a new password.

Workspace status: Checking

Final signal assessment, regulatory interpretation, and submission decisions remain the responsibility of qualified PV/medical reviewers and the MAH.

PV
VigiCore

OnePV Platform

OnePV Workspace

Workspace Shared PV Portal Controlled access

OnePV Shared Workspace

OnePV Home

Choose an enabled pharmacovigilance application from your shared OnePV workspace.

RolePending
User IDLoading
SessionAuto logout after 15 min inactivity

One Login. One Workspace.

Welcome to OnePV

Use this shared pharmacovigilance portal to open enabled PV applications for your tenant. Signal Automation, Literature Monitoring, and PSMF are available in the OnePV staging workspace.

Access is role and tenant controlled Only applications enabled for your workspace can be opened.
Available

VigiCore Signal Automation

Run statistical signal detection, review results, gather supportive evidence, prepare SER drafts, and generate SRC briefing packs.

Available

Literature Monitoring

Controlled literature screening, monitoring, review workflows, and literature evidence tracking.

Available

PSMF Tool

PSMF readiness, controlled documentation workflows, and governance-supportive workspace controls.

Planned

Future PV Apps

Additional pharmacovigilance modules can be added to the same OnePV workspace without changing the user login flow.

Important workspace context

OnePV is a shared portal shell. Each application keeps its own controlled workflow, audit trail, and tenant boundary. Disabled modules cannot be opened until they are configured and approved for your workspace.

Available

Literature Monitoring

Literature Monitoring is available as a separate OnePV application and opens in its own controlled workspace.

Available

PSMF Tool

PSMF Tool is available as a separate OnePV application and opens in its own controlled workspace.

Platform Admin

OnePV Admin

OnePV Admin is not enabled yet. Platform-level tenant controls, app access packages, and shared workspace administration will appear here when approved.

Tenant accessPlanned for controlled app entitlements.
Application packagesSignal, Literature, PSMF, and future PV modules.
Production safetyLocked until production readiness is explicitly approved.

1. Run Signal Detection

Upload a safety line listing, confirm column mapping, choose the shrinkage method, and generate SDR outputs.

2. Review Current or Past Runs

Open results, inspect calculations, view generated reports, and load run-specific analytics.

3. Validate and Gather Evidence

For one flagged DEC, run FAERS/EU evidence, PubMed literature validation, or internal case-series validation.

4. Governance and Audit

Manage thresholds, user access, historical runs, comparison reports, and audit trail exports.

Tracked Clients 0 Recorded Runs 0 Latest Triggered SDRs 0

Recent runs

Select a row below or choose a report when prompted. The dashboard will not silently open the latest run.

S.No. Run Name Client Name Run Date/Time Data Cutoff User Report Filter Excel Output PDF Output Action
No runs loaded.

Create Signal Detection Run

Every new run is fresh by default. A baseline is not applied automatically. Use Compare Runs only when you explicitly want a comparison.
No source file uploaded for the selected run.

Input Preview

Load preview to inspect the uploaded source file.

Column Mapping

Confirm how the uploaded client file maps into VigiCore's standard internal schema. Required fields must be mapped before analysis.

Required fields control what enters the signal engine. Optional fields improve filtering, traceability, and report context.
Signal model for this run

The selected shrinkage method controls which Bayesian columns appear in the report.

Required fields Approve these before analysis.
Optional fields for traceability and reports
Advanced mapping options
Upload a source file, review the detected mapping, then confirm before execution.
Mapping confidence will appear after preview.
Data quality summary will appear after mapping validation.
Detected sheets and columns
Detected sheets
Not available
Detected columns
Not available

Source preview

Top source rows

Upload a file to inspect the detected source preview.

Settings

Applies to future runs. Calculation thresholds are controlled here. Source-specific fields, seriousness source, and file structure approval are handled in Column Mapping. Seriousness supports serious case count and prioritisation only; it does not change PRR/ROR/Chi-square/EBGM/IC.
Priority Mapping

Used when the approved import mapping provides P1-P5 style priority values. If a source file uses Case Seriousness, Event Seriousness, Seriousness Criteria, Fatal Flag, or Outcome instead, the reviewer selects that source during Column Mapping.

Results Viewer

Review checks
Medical reviewer comments Optional. Saved comments are included in the SDR PDF/Word report when “Include in report” is selected.
Not saved yet. Comments are optional.
Recommended PDF scope includes signal-detected and monitoring/caution rows only. Full All Pairs remains available in Excel/CSV and Results Viewer.
Select one flagged DEC for EU, Validation, or Literature. FAERS can be run for selected flagged DECs. Double-click N, Serious Case Count, PRR, ROR, active shrinkage metrics, Chi-square, PRR lower bound, or Top Country for explainability.
No run executed yet.
FAERS S.No. Drug Event PT N Serious PRR ROR Chi-square PRR LB Status Stability Bayesian View
Execute or load a run to preview signal output here.

Signal Review Analytics

Graphical run summary and priority signal queue. Analytics uses stored outputs only and does not change SDR status.

Run analytics will appear after a run is selected or executed.
Model context: select a run to see whether MGPS-style, IC-style, or no-shrinkage analytics apply.

Historical Runs

Historical Runs is a controlled run registry. It reopens saved outputs for review and comparison; it does not recalculate signal results.

Select one saved run from the registry below, then choose Results, Reports, Analytics, or Compare.

Select one run row. If the stored result output is unavailable, the app will show an error rather than silently recreating or assuming results.

S.No. Run Name Client name Run date/time Data Cutoff User Report filter Status Source system Excel output PDF output Comparison / report paths Action
No runs loaded.

Compare Runs

Compare Runs supports trend and re-signalling review. It uses saved outputs only and does not recalculate original signal detection runs.

Comparison reviewer comments Optional. Saved comments are included in the comparison PDF/Word report when selected.
Not saved yet. Comments are optional.
Select exactly two saved runs. Compatibility is validated before comparison report generation.
Comparison outputs will appear here once two compatible runs are selected.
S.No. Drug Event PT Change Category Previous N Current N Previous PRR Current PRR Previous ROR Current ROR Previous EB05/IC025 Current EB05/IC025 Previous Chi-square Current Chi-square Previous PRR LB Current PRR LB Delta N Delta PRR Delta ROR Delta EB05/IC025 Previous Bayesian View Current Bayesian View Previous Status Current Status Reviewer Interpretation
Generate a comparison report to preview DEC-level movement.

Report Preview / Export

Controlled output center for generated SDR, comparison, validation, literature, FAERS, and EU evidence reports. Reports are retrieved only; this page does not recalculate signals or change evidence interpretation.

No reports generated yet.

Select a report row to retrieve the stored output. If the registered file is not browser-openable, the workspace shows a controlled reference instead of regenerating it.

S.No. Run Name Client name Report type Output Generated date/time Status Storage Archive Action
No generated reports are listed yet.

Report Review Workspace

Add human reviewer interpretation before creating a reviewed final package for SDR, FAERS, EU, literature, or internal validation reports. Reviewer Support does not change the source report or signal status.

Select a report from Reports, then click Review Selected Report.
Completeness support has not been run yet.

Writing Support

Quiet review checks

Optional reviewer-support checks. No source report or signal status is changed.

Review notes will appear here only after you run a check.
No suggested wording decision recorded yet.
Select a saved run or load a run from Results Viewer before drafting the SER.
Start by selecting one internally flagged signal for this SER.
Signal selection and evidence summary will appear after a run is selected.

Reviewer Support

Writing Support and SRC Briefing

Optional reviewer support controls. The SRC briefing pack is decision-focused and does not change stored signal results.

Open a Draft SER to view optional writing support and SRC briefing actions.
Completeness findings will appear after draft loading or check.
Open a Draft SER to load section-level reviewer fields.
Evidence snippets will appear after a Draft SER is opened.
Draft not edited in this session.

Validation

Internal Case-Series Validation

Prepare one internal case-series validation package for one flagged DEC. This does not recalculate the SDR.

No DEC selected. Select one internally flagged DEC from Results Viewer to continue.

Upload and map

Line Listing and Optional Narrative

  1. 1Line listing
  2. 2Line mapping
  3. 3Narrative optional
  4. 4Narrative mapping if uploaded
  5. 5Report
No DEC selected Waiting for line listing upload Mapping pending No validation report generated
No validation report generated in this browser session.

Literature Search

PubMed literature validation is supportive only. It does not confirm, refute, or change the internal SDR status.

Select one flagged DEC from Results Viewer to begin literature validation.
Select a flagged DEC from Results Viewer or choose a saved run and flagged DEC above.
PubMed results will open in a dedicated review workspace after search completion.

Audit Trail

PV Audit Event Register

Total Events0
Last ActivityNot available
Integrity StatusHash-chain ready
Warnings / Failures0
Date/Time User Action Area Run / Report Outcome Event Details Open
Audit events will appear after activity is recorded.

User Management

System Admin only. Create users, assign roles, reset access, and control tenant account lifecycle.

Testing data reset

Clears tenant test runs, uploads, generated outputs, and run records before UAT/demo. Cognito users, settings, SharePoint configuration, and audit history are preserved.

System Admin only. Current admin sign-in password required.
S.No. Name User ID Email Role Status Actions
No users loaded.

Processing...

VigiCore Help Center

User Guide

Search features, workflows, reviewer support, and SER drafting guidance.

Calculation Transparency

DEC detail

Literature Results

PubMed Article Review Workspace

Review retrieved articles, add reviewer comments, and export controlled evidence.

PMID Title Journal / Year Suggested relevance Reviewer relevance Reviewer comment PubMed link Main article link Abstract preview
Search PubMed to load articles.
Select one article row to review abstract, classification rationale, and reviewer comment.
Page 1 of 1

Reviewer Workflow

Workflow

Select one DEC row in Results Viewer to continue.
FAERS/openFDA supportive evidence

Runs only for internally flagged DECs marked in the FAERS column. FAERS evidence is supportive context only and never changes internal SDR calculations.

Evidence reviewer comments Optional. Saved comments are included in the FAERS PDF/Word report when selected.
Not saved yet. Comments are optional.
No FAERS check executed in this browser session.
EU evidence CSV support

Upload an exported EU/EudraVigilance CSV or Excel file, confirm mapping, then generate supportive evidence report. EU data is never used in internal SDR math.

EU evidence reviewer comments Optional. Saved comments are included in the EU PDF/Word report when selected.
Not saved yet. Comments are optional.
No EU evidence report generated in this browser session.
Internal case-series validation report

Requires exactly one internally flagged DEC. The validation workspace will open with the selected drug/event and saved run context.

PubMed literature validation

Requires exactly one internally flagged DEC. The literature page will auto-fill the drug, event, run ID, and broad PubMed search string.