Adverse Event Intake from Emails and Calls

• Head of Pharmacovigilance
• Drug Safety Associate
• Medical Information Manager
• Pharmacovigilance Officer In-Charge

Possible adverse events reach a pharma company through many doors: the medical information inbox, customer care calls, product complaints, MR visit notes and distributor emails. Each one has to be recognised, captured with enough detail to form a valid case and passed to the safety database within reporting timelines.

We build an intake layer that watches the channels you choose, such as the medical information mailbox, customer care call recordings and MR call reports, and flags text that may describe an adverse event, special situation or product complaint. For each flagged item it extracts the four minimum criteria for a valid case, plus product, batch, dose, dates and outcome where present, and drafts an intake form and narrative with each field linked to its source sentence. Calls in Hindi and other Indian languages are transcribed first. Your PV team verifies, completes and submits; the system never assesses seriousness or causality.

• Screens emails, call transcripts, MR reports and complaint records for possible adverse events and special situations
• Extracts identifiable patient, reporter, suspect product and event: the minimum criteria for a valid case
• Captures batch, dose, onset date, outcome and concomitant medicines when mentioned
• Transcribes and translates calls in Hindi and regional languages, keeping the original text
• Drafts an intake form and narrative with every field linked to its source
• Records the first-receipt date and time for each report to support timeline tracking

1. 01Monitor intake channelsConnectors pull new emails, call recordings, MR reports and complaint records from the agreed channels.
2. 02Transcribe and screenCalls are transcribed, and every item is screened for possible adverse events, special situations and complaints.
3. 03Extract case detailsFor flagged items, the minimum criteria and other case details are extracted with links to the source text.
4. 04Draft the intakeAn intake form and narrative are drafted, with missing criteria listed as follow-up questions instead of being filled in.
5. 05Safety associate verifiesA drug safety associate reviews the draft, corrects fields, decides whether it is a valid case and requests follow-up if needed.
6. 06Hand over to the safety databaseThe verified intake goes into the safety database through an import or form, with the audit trail attached.

1. Channel intake
   • Medical information mailbox connector
   • Call recording feed from the contact centre
   • MR call report export from CRM
   • Complaint system feed
2. Speech and language
   • Speech-to-text for Hindi, English and regional languages
   • Translation to English with the original retained
3. Screening and extraction
   • Adverse event and special situation classifier
   • LLM extractor for case criteria and details
   • MedDRA term suggestions for the reviewer
4. Review and handover
   • Safety associate review queue
   • Safety database import or form fill
   • Timeline and audit log

A trained drug safety associate verifies every flagged item and decides whether it is a valid case. Seriousness, expectedness, causality and MedDRA coding are confirmed by your PV team, and PV samples items screened as no event to check for misses.

• Safety database such as Oracle Argus, ArisGlobal LifeSphere or an in-house system
• Email platform such as Microsoft 365 or Google Workspace
• Contact-centre recording platform
• Pharma CRM used by the field force
• Complaint management system or QMS

• Screening tuned to favour catching events, with PV sampling of items screened as no event
• No field is filled unless the source text supports it
• Original-language text kept alongside every translation
• Patient and reporter details masked in logs and restricted by role
• Models and prompts under change control

• Supports the pharmacovigilance obligations of marketing authorisation holders, including adverse drug reaction reporting in India under CDSCO and PvPI guidance.
• Output fields can be structured towards ICH E2B(R3) data elements for downstream case submission.
• Patient and reporter data is handled in line with the DPDP Act 2023 and, where relevant, GDPR.

• Pharma & Life Sciences

  Medical Rep Call Reporting by Voice

  Medical representatives speak a short note in Hindi, English or a regional language after each doctor visit, and the agent drafts the call report, sample entries and follow-ups for them to confirm.

• Pharma & Life Sciences

  Doctor Engagement and Sample Request Automation

  Consent-based WhatsApp and email journeys that send MLR-approved content to doctors, capture sample and literature requests, and route each one to the right MR or team with a full record.

• Pharma & Life Sciences

  Validation and Security Testing of AI Tools in GxP Settings

  Risk-based testing of LLM and ML tools used in quality, manufacturing or pharmacovigilance: accuracy, prompt injection, data leakage and audit-trail checks, packaged as validation evidence.

• Healthcare & Hospitals

  Safety and Patient-Data Leakage Testing for Healthcare Chatbots

  Test patient-facing chatbots and voice bots for unsafe medical advice, missed emergency escalation, invented information and cross-patient data leakage, with clinician-reviewed evidence.