vGenixOS / Pharmacovigilance Intelligence
The safety science behind every decision
Pharmacovigilance Intelligence gives vGenixOS the medical and safety knowledge an experienced safety professional brings to every case: dictionaries, concepts, clinical context and your own conventions.
Related terms grouped
Shown on every term
Pharmacovigilance Intelligence at a glance
MedDRA coding
Every reported event is coded from the reporter’s own words to the right MedDRA term, with the full hierarchy shown so reviewers can see exactly where it sits.
- Verbatim text mapped to the lowest level term and preferred term
- Your coding conventions, synonym lists and house rules applied
- Confidence and alternative terms shown for review
- MedDRA version upgrades handled under change control
Example coding. Confidence and alternatives are shown to the reviewer.
WHO Drug coding
Suspect and concomitant products are coded to WHO Drug, including local trade names, strengths and formulations, so every product is recognised however it was reported.
- Trade names, generics and local brands resolved to the right entry
- Active ingredients and ATC classification attached
- Strength, form and route captured with the product
- Unrecognised products flagged instead of guessed
Safety assessments
Seriousness, expectedness and causality are assessed the way your SOPs define them, and every assessment shows the rule and evidence behind it.
- Seriousness against ICH E2A criteria and your SOP definitions
- Expectedness checked against the current reference safety information
- Reporter causality captured; company causality left to your experts
- Every assessment links to the rule and source text it used
Clinical context
An event means different things in different patients. Medical history, concomitant medicines, indication and population are read together, so nothing important is assessed in isolation.
- Medical history and risk factors captured and coded
- Concomitant medicines checked for alternative explanations
- Special populations flagged: children, pregnancy, older adults
- Context passed to reviewers alongside the assessment
Your products
Each product’s reference safety information is held as structured knowledge, version-controlled, so expectedness is always assessed against the version in force on the right date.
- Listed events held for every product and formulation
- Versions tracked with effective dates
- Expectedness checked against the version in force
- Updates applied under change control with full history
| Product | RSI version | Listed events | Effective |
|---|---|---|---|
| Product [A] | v[__] | [__] | [date] |
| Product [B] | v[__] | [__] | [date] |
| Product [C] | v[__] | [__] | [date] |
Placeholder rows: populated from your product information during setup.
Neural understanding, symbolic checks
Like every part of vGenixOS, Pharmacovigilance Intelligence pairs AI that understands with rules that verify, so every result can be explained.
Understand
Neural AI reads the clinical text the way an expert would
Map
Terms mapped to MedDRA, WHO Drug and your products
Check
Symbolic rules apply your SOP criteria
Explain
Every result shown with its reasoning and confidence
Powering every module
One intelligence, shared by all five modules through Collective Intelligence.
Signal management
Groups related medical concepts so signals are not split across terms
Explore →Use it on its own
Pharmacovigilance Intelligence is also available through secure APIs, inside the systems you already run.
Explore IntaaS →Under your control
Coding conventions and SOP criteria are configured with your team, validated before go-live, and changed only under change control.
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