Alerta™ by Botco.ai

AI-Driven Automation for Pharmacovigilance Case Processing

Pharmacovigilance case processing is consuming two-thirds of pharmaceutical companies’ safety resources, with each adverse event report requiring approximately 40 minutes of skilled staff time. As pharma companies face millions of FAERS, EMA, and WHO reports annually while patient and healthcare provider interactions shift to digital, omnichannel formats, manual workflows can no longer keep pace. Delays or missed reports expose organizations to regulatory penalties, patient safety risks, and brand damage. The industry needs an intelligent, automated solution that can scale PV operations without adding headcount—and that solution is Botco.ai Alerta™.

How Botco.ai Alerta™ Works:

Real-Time Detection Across All Channels – Alerta™ reviews call center transcripts, chat conversations and digital interactions to identify adverse events (AEs) and product quality complaints (PQCs) the moment they occur, ensuring nothing slips through the cracks.

Intelligent AI Scoring & Triage – Trained on millions of pharmacovigilance data points, Alerta™ automatically scores severity and expectedness using your product labeling and FAERS patterns, prioritizing cases that require immediate attention and reducing manual review burden.

Automated Case Completion & Reporting – From day-zero acknowledgement to missing field collection via SMS or secure web forms, Alerta™ auto-generates regulatory-ready case reports in XML/R3 format, reducing turnaround time from 72 hours to just minutes.

Seamless Integration & Compliance – Designed to plug directly into existing PV workflows and safety systems, Alerta™ maintains complete audit trails with field-level PHI/PII encryption, SOC 2 Type II certification, and HIPAA compliance—meeting the rigorous standards required for regulatory inspections.

With Botco.ai Alerta™, pharmaceutical companies can transform their pharmacovigilance operations by capturing every adverse event 24/7 across all patient-facing channels, cutting case processing time from hours to minutes, and scaling their safety operations without expanding headcount. By automating detection, triage, and reporting, Alerta™ frees PV teams to focus on what matters most—medical review and patient safety—while reducing costs, eliminating regulatory risk, and ensuring no adverse event goes undetected. Deploy in weeks, see results immediately, and gain the competitive advantage of AI-powered pharmacovigilance.