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OpenSAFETY.iO

For MAHs. Literature monitoring. Shared signals.

Pharmacovigilance collaboration for MAHsShare screening and signals.

You must monitor the literature. So must every other MAH. Often you read the same articles. OpenSafety.iO lets you share screening results and signal clues. You still own your cases and filings.

Documentation

Live preview

Live workspace preview

Read the literature. Check FAERS. Compare. Share notes. Each MAH still owns its own decisions.

Screen articles for adverse events
LLM assist
Search“metformin”

Example output

Signals: reviewed

Safety-related text

Pulls text that may matter for cases or labels. Not just keyword matches.

Traceable to the source

Links back to the article. Reviewers can show their work.

Built for regulated work: traceable notes, shared screens where policy allows, human sign-off.

Meet the rules

You still monitor literature. You can reuse others’ screens when your policy allows. Less repeat work.

Your duty stays yours

Sharing notes does not move legal duty. Your QPPV and medics still sign off.

Help, not autopilot

AI can triage first pass. Humans still decide causality and filings.

Signals in one place

Put literature and FAERS next to each other. Wider view. Same audit trail.

Tools

All tools in one place

PubMed, libraries, FAERS, cross-check. Built to work together.

PubMed Intelligence

Screen PubMed for safety text. Share results when your rules allow.

Literature Analysis

See what you already reviewed. See what is still open.

Reviewed Library

One list of reviewed articles. Everyone pulls from the same record.

Public Archivals

Browse shared reviews by drug and date. Fewer repeat screens.

More tools

Blog

Short posts on FAERS, MedDRA, and how shared work fits your duties.

FAERS Explorer

Explore FAERS for hypotheses. It is not a rate study.

Cross Reference

Read articles and FAERS together. Same story or not?

FAERS Checker

Check if events from an article also show in FAERS for that drug.

How it works

Three steps

Screen articles. Check FAERS. Compare and file notes.

Step 01

Screen articles

Find cases and label issues. Save structured notes. Share when rules allow. Others skip duplicate reads.

Step 02

Check FAERS

Add spontaneous data next to literature. Look for patterns. Remember duplicate reports and unknown use.

Step 03

Compare and document

Line up articles, shared notes, and FAERS text. One record for medics and audits.

Read the docs
Quick demo

Try the flow

PubMed. FAERS. Cross-ref. Same as a real review pass.

Example request
Preview only
Which metformin articles mention adverse events?

What you get

  • Text flagged for cases or labels
  • Notes with PMID
  • Export for your signal file

Built for real PV work

You must trace your steps. The app keeps queries, notes, and FAERS in one place. Audits get easier.

Show your sources

Tie answers to PMIDs and FAERS pulls. Not loose spreadsheets.

Share work, not blame

Less repeat reading. Each MAH still decides and files for itself.

Data has limits

FAERS is biased. Articles miss things. We do not fake incidence or causality.

Get help
FAQ

Common questions

Short answers. Ask support if you need more.

Frequently asked questions

MAHs share literature screening and signal insight here. The same article gets fewer repeat reads. Each MAH still meets its own legal duties.

Start your workspace

Share screening. Cut duplicate reads. Keep your own filings. Open an account to begin.

Read documentation