Intake triage
Classify inbound reports, route duplicates, and flag missing details for follow-up.
Pharmacovigilance
Safety / PV
Reduce noise in case intake and literature review so safety professionals can focus on the judgment calls that actually matter.
Case support without diluting safety review
Agents can pre-sort submissions, draft narratives, and gather references, but safety assessment always stays with trained humans.
Operating layers
Govern · Prepare · Build · Validate · Scale
Decision rights
Human-owned, evidence-backed.
Concrete workflow example
Case intake completeness and narrative draft
Faster case preparation while medical safety judgment remains with trained reviewers.
Inputs
- • case intake
- • structured safety fields
- • source notes
- • literature references
- • follow-up requests
Agent tasks
- • pre-sort cases
- • flag missing details
- • draft narrative from approved fields
- • compile references
- • track follow-up
Evidence output
- • source field map
- • draft/review history
- • missing information log
- • reference packet
Where agents fit
Useful work, not magical work.
These are the places where a governed agent saves time without taking over the decision.
Narrative drafting
Prepare a first-pass case narrative from approved source fields and notes.
Literature support
Pull candidate references and summarize why they matter to the case.
Follow-up management
Track unresolved questions, response status, and required evidence.
Use cases
What the team can actually do.
Pre-sort case intake by source, completeness, and urgency.
Draft case narratives from structured fields and approved notes.
Compile literature and reference summaries for medical review.
Track follow-up requests and missing source documents.
Prepare review bundles for signal detection and case review meetings.
Human decision points
Humans own the regulated decisions.
causality
seriousness
expectedness
reportability
signal interpretation
What agents cannot do
No hidden authority.
suppress or close a case
make medical determinations
decide reportability
discard safety information
Controls and governance
The brakes are part of the design.
If the workflow touches regulated records or operational decisions, the controls need to be visible, testable, and boring.
No causality, seriousness, or expectedness determinations are automated.
The agent cannot suppress, discard, or close a safety item by itself.
Source records and review history stay attached to each draft.
Escalation rules are validated for the intended intake pathways.
Human team role
Domain specialists stay accountable.
Safety physicians, PV specialists, and case reviewers make the medical decisions and own regulatory reporting obligations.
Common systems
safety databaseliterature sourcescase intakesignal trackingmedically reviewed notes
Next step
Pick the first workflow worth doing properly.
Start with one bounded use case, prove the controls, and then decide whether the pattern deserves to spread.
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