Solutions / Medicinal products
Pharmacovigilance for medicinal products
Case processing, literature, signals, periodic reports and submissions for prescription, OTC and biological medicines, including vaccines, across every market you serve.
Vigilance for medicinal products
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. For medicinal products it is the most mature and most regulated vigilance area.
Marketing authorisation holders must collect and assess individual case safety reports, monitor the literature, detect and manage signals, submit periodic benefit–risk reports and maintain risk management plans, all within fixed regulatory timelines and in harmonised formats such as ICH E2B (R3).
The main requirements
| Region | Regulation | Key obligations |
|---|---|---|
| European Union | Directive 2001/83/EC, Regulation (EC) 726/2004, Implementing Regulation (EU) 520/2012, GVP modules | ICSRs to EudraVigilance, literature monitoring, PSURs, signal management, RMPs, QPPV and PSMF |
| United States | 21 CFR 314.80 (drugs), 21 CFR 600.80 (biologics), 21 CFR 312.32 (IND safety) | 15-day alert reports, periodic reports (PADER), IND safety reports |
| International | ICH E2A, E2B (R3), E2C (R2), E2D, E2E, E2F | Harmonised definitions, formats and periodic reports |
| Other markets | Local requirements, for example MHRA, Health Canada, CDSCO (PvPI) | Local reporting rules, formats and languages |
A summary for orientation, not legal advice. Always check the current regulations and guidance for each market.
What makes medicinal products hard
High, constant volume
Hundreds of thousands of cases a year for large portfolios, each on a clock.
Many sources
Spontaneous, clinical trial, literature, partner, patient programme and digital sources.
Many markets
Different timelines, formats and local rules in every country.
Vaccines and biologics
Batch-level tracking, special populations and heightened public scrutiny.
Periodic reporting load
PSURs, PBRERs, DSURs and PADERs across the product lifecycle.
Inspection readiness
Every decision traceable and every SOP demonstrably followed.
One platform for medicinal products
The same modules, intelligence and controls used across every vigilance domain, configured for this one.
Why teams choose vGenix Ai
Full lifecycle on one platform
Safety data from clinical development and post-marketing lives in one data model, so nothing is lost when a product moves from trials to market.
- Clinical trial cases, SUSARs and DSURs alongside post-marketing work
- One product record across the whole lifecycle
- Signals informed by both clinical and post-marketing data
- No migration when a product is approved
Built on ICH and GVP
Internationally agreed definitions, formats and timelines are built into the platform’s rules, so your team starts from the standard rather than rebuilding it.
- ICH E2A definitions for seriousness and expectedness
- ICH E2B (R3) data elements and business rules
- ICH E2C (R2) structure for PBRERs
- EU GVP modules reflected in workflows and timelines
| Standard | Where it applies |
|---|---|
| ICH E2A | Seriousness, expectedness, timelines |
| ICH E2B (R3) | Case data and submission |
| ICH E2C (R2) | PBRER structure |
| ICH E2F | DSUR structure |
| EU GVP VI · VII · IX | ICSRs, PSURs, signals |
Vaccine-ready
Vaccine safety brings its own details: batch and lot numbers, dose numbers, special populations and adverse events following immunisation. They are captured as structured data from the start. See our vaccine vigilance page for more.
- Batch, lot and dose number captured on every case
- Pregnancy, paediatric and older-adult cases flagged
- Adverse events following immunisation handled consistently
- Batch-level patterns visible in signal detection
[Confirm vaccine-specific capabilities before publishing.]
Your SOPs, configured
Case rules, coding conventions, review gates and templates are configured from your own procedures, validated and version-controlled.
- Validity, seriousness and expectedness rules from your SOPs
- Your MedDRA and WHODrug coding conventions
- Review and sign-off gates where your SOPs require them
- Every configuration change approved and versioned
Every market
Local reporting rules, formats and languages are configured for each market you serve, so one case meets every authority’s requirements.
- Destinations and timelines per market
- Local formats and data elements
- Multilingual intake and translation
- Partner exchange obligations included
| Market | Rule | Due |
|---|---|---|
| EU | Serious · 15 days | Day 15 |
| United States | 15-day alert report | Day 15 |
| [Market] | [Local rule] | [Due] |
| Partner [Name] | SDEA | [Due] |
Inspection-ready
Every value is linked to its source, every action is in the audit trail, and validation evidence is produced as the system is configured.
- Source links on every extracted value
- Complete audit trail for human and AI actions
- Validation evidence from implementation
- Searchable history for any inspection question
[Confirm which domain-specific terminologies, forms and gateways are live for medicinal products before publishing.]
One platform for every vigilance domain
Run all your vigilance domains on the same data model, rules engine and audit trail.
Intelligent safety should be one connected operation
Automate the work. Keep the decisions with your experts. Keep the evidence traceable. See it on your own data in six weeks.
6-week pilot on literature monitoring
- Baselines agreed up front
- Configured to your SOPs
- Measured on your own data
- Validation evidence from day one