AI Pharmacovigilance Agent for Adverse Event Processing

A pharmacovigilance agent captures adverse event reports from intake channels such as email, call transcripts, web forms, and literature, extracts them into structured case data, detects duplicates, and supports triage. Your case processors and medical reviewers approve every output. Kanerika builds and runs the agent inside your own environment, aligned to your SOPs.

No. The agent removes re-keying, duplicate searching, and first-pass structuring, which is where case processing hours actually go. Validity decisions, seriousness assessment, causality, narrative approval, and submissions remain with your qualified people. Each draft arrives with its sources attached, so review means checking evidence rather than reconstructing the case from scratch.

Typical deployments cover shared safety inboxes, call center transcripts, web intake forms, partner report exchanges, and literature feeds. Kanerika connects the channels you actually run, in the order that removes the most manual entry first. Paper and fax-based sources can be included through your existing scanning workflow, with the same source-traced extraction applied.

The reporting clock starts at first receipt, so the agent timestamps every report on arrival, checks validity criteria immediately, and orders the queue by deadline and seriousness indicators. Expedited candidates surface at the top the day they arrive rather than when someone opens the inbox, protecting the days your reviewers need.

Yes. The agent screens literature sources against your product list and queues articles that may contain reportable adverse events for professional review. Screening decisions are documented either way, including what was set aside and why, which is exactly what inspectors ask for when they test the rigor of a literature surveillance process.

Case data never leaves your tenant, is never used to train outside models, and inherits your access controls and retention rules. Kanerika holds SOC 2 Type II, ISO 27001, ISO 27701, and ISO 9001:2015 credentials and operates GDPR-compliant processes. Where workflows need de-identified data, Kanerika also builds dedicated PII redaction with Susan.

Yes. The agent sits in front of your safety database rather than replacing it, preparing structured, reviewed case data for entry or import through your established process. Your pharmacovigilance and drug safety software stays the system of record. Kanerika scopes the integration pattern during setup, matching whatever validation boundaries your quality team has defined.

Kanerika’s pharma engagements are largely confidential, so the citable evidence is adjacent. A Kanerika compliance agent made expert vetting three times faster, and an AI regulatory management platform cut manual compliance work by 60%, both linked on this page. Both involved regulated review work with human experts keeping final authority over outcomes.

Check that every extracted field links back to its source document, call transcript, or article, because inspectors will ask. The software should capture reports from email, call centers, web forms, partners, and literature, catch duplicates before they enter the workflow, and order cases by reporting clock and seriousness. Validity, causality, and submission decisions should stay with your reviewers. Kanerika’s agent works this way inside your tenant, alongside your safety database.

Keep people on every medical judgment and log every step the automation takes. With this agent, case processors and medical reviewers approve each output, every extracted value references its source, and literature screening decisions are documented, including articles set aside. Configuration is versioned, and the pilot measures accuracy case by case before any intake stream expands. Reconstructing a case history for an inspection then takes minutes.