AI agent · Life sciences · Read & extract
Adverse event intake
Safety reports arrive in every format, and the reporting clock starts when anyone in the company first receives them. The agent reads each report, drafts the case with every field traced to its source, and leaves the medical judgement to your reviewers.
Typical volumes for this process, not a client figure.
Reports arrive by email, call notes and literature; each one is keyed into the safety database.
Read, fields extracted with their source, case drafted for a safety reviewer to confirm.
Where the time goes today
Adverse event information reaches a company through many doors: the medical information line, sales representatives, patient support programmes, partner companies, literature searches, social media monitoring, and plain email. Under the applicable pharmacovigilance rules, the reporting timeline usually starts on the day anyone in the organisation first holds the minimum information, not the day the safety team opens it. Intake staff read each item, decide whether it is a valid case, look for duplicates, and key the case into the safety database.
Keying is where the hours go. A single report can carry patient age and sex, reporter details, several products with doses and batch numbers, start and stop dates, each event in the reporter's own words, outcome, medical history and concomitant medication. Much of it comes as free text or a scanned form, and literature articles may describe several patients at once.
The errors that matter are specific. A day-zero date taken from the forwarding email instead of the original receipt. A seriousness criterion stated in the narrative but not ticked on the form. The same event reported by the patient and the physician and entered twice. An adverse event hidden inside what was logged as a product quality complaint.
How the agent works
- Receive and dateThe agent captures each item from every intake channel and sets day zero from the earliest receipt anywhere in the company, recording which evidence the date came from.
- Check validityIt tests for the four minimum criteria: an identifiable patient, an identifiable reporter, a suspect product and an adverse event. An incomplete report is never discarded; it is held and a follow-up request is drafted.
- Extract with sourcesIt extracts patient details, reporter, products, doses, batch numbers, dates, events verbatim, outcome and seriousness wording. Every field links to the sentence or form box it came from.
- Search for duplicatesIt compares patient characteristics, product, event dates and reporter against existing cases in the safety database and lists likely duplicates for the reviewer.
- Draft and prioritiseIt creates a draft case with suggested coding from your dictionary, orders the reviewer queue by reporting due date, and moves reports with serious or fatal wording to the top.
What stays with a person
Every draft is confirmed by a safety reviewer before it becomes a case. Seriousness where the text is not explicit, causality, expectedness against the reference safety information, final coding, and the decision to submit all stay with qualified people under your procedures. The agent does not submit anything to an authority or a partner.
The agent also never decides on its own that a report is not a case. Missing an adverse event is the error with the highest cost, so every report the agent considers invalid or out of scope is listed for a person to confirm. That keeps the review threshold where the arithmetic puts it: reviewing a few extra items costs minutes; a missed case can cost far more.
What it reads, what it produces
| It reads | It produces |
|---|---|
| Safety mailboxes and forwarded emails, with attachments | A draft case per valid report, each field linked to its source |
| Medical information call notes and patient support programme records | Day zero and the reporting due date, with the evidence for the date |
| Literature search results and partner exchange files | Follow-up questions drafted for missing information |
| The safety database, for duplicate search and follow-ups | A list of likely duplicates for the reviewer |
| Your product dictionary, coding dictionary and pharmacovigilance procedures | Product quality complaints split out and routed to quality |
Controls that come with it
- No report is closed as invalid without a person confirming it
- Day zero always taken from the earliest receipt in the company
- Reports with serious or fatal wording always moved to the top of the queue
- Drafts only: case approval and submission require a qualified reviewer
- A daily reconciliation: every item received in every channel is accounted for as a case, a follow-up or a confirmed non-case
- Validated as a computerised system under your quality procedures, with a fixed test set rerun after each change
How you know it works
- Time from receipt to draft case in the database
- Fields corrected by reviewers, broken down by field
- Cases submitted after their due date
- Duplicates found after case creation
- Items unaccounted for in the daily reconciliation
Is your process ready?
- Written rules: your pharmacovigilance procedures already define validity, day zero and seriousness. The agent needs them as written, including the local variations for each market you report to.
- Systems: the safety database must accept drafts by interface or structured import, and your vendor contract must permit automated case creation. Check this early; some licences restrict it.
- Cheap check: a reviewer confirms every case anyway, so each extraction is checked at no extra cost, which is what makes this process a candidate.
- Volume: dozens of reports a day across channels repays the build and the validation effort; a handful a week does not.
- One description: medical information, patient support and partner teams often forward reports differently. Agree one intake route and one day-zero rule first.
The five candidacy checks are explained, with an exam, in the free Module 01.
What goes wrong
- Literature articles describing several patients produce several cases, and the split is easy to get wrong.
- Reports in other languages need a translation step that is itself checked, or a reviewer who reads the language.
- Social media posts rarely carry an identifiable reporter and flood the queue if the filtering is loose.
- The validation effort is underestimated; plan it with your quality team before the build, not after.
Questions we get
Does the agent assess seriousness or causality?
It flags seriousness only where the report states it in words, such as hospitalisation or death, and shows the sentence. Implicit seriousness, causality and expectedness are medical judgements and stay with your reviewers. The agent's job is to put a complete, traceable draft in front of them faster than keying would, and to make sure nothing received is lost on the way.
How is the agent validated?
As any computerised system used in pharmacovigilance: a documented intended use, a test set of past reports with known-correct cases, acceptance criteria per field agreed with your quality team, and change control. The same test set is rerun after every model, prompt or rule change, so you know before release whether extraction on a field has moved.
Can it submit cases to authorities or partners?
No. Submission follows your procedures and is triggered by a qualified person after case approval. The agent can prepare the information in the structure your safety database needs, and it tracks due dates, but the decision and the act of sending remain with people. That is a design choice, not a technical limit.
What about reports in several languages?
The agent can read reports in the languages you specify and extract the fields, keeping the original text alongside any translation of event terms. Verbatim wording is preserved in the source language for the reviewer. Where your procedures require a certified translation for certain report types, the agent flags them rather than relying on its own reading.
Want this agent on your process?
Tell us about your version of this process — volumes, systems, what goes wrong. A person answers with an approach and a price, usually within two working days, or tells you it is the wrong project.