AI-Powered Pharmacovigilance Platform

  • AI-powered automation covering many countries globally
  • Fixed & predictable cost — no per-case fees
  • Fully integrated digital platform (expert oversight, safety, literature, local PV)
AI Pharmacovigilance Background
# AI Pharmacovigilance # Global Coverage # Touchless Processing # Signal Detection # PV Experts # Literature Monitoring # Safety Reporting # Local PV # Risk Management # Regulatory Intelligence # Quick Setup # Zero Admin Costs # AI Pharmacovigilance # Global Coverage # Touchless Processing # Signal Detection # PV Experts # Literature Monitoring # Safety Reporting # Local PV # Risk Management # Regulatory Intelligence # Quick Setup # Zero Admin Costs # AI Pharmacovigilance # Global Coverage # Touchless Processing # Signal Detection # PV Experts # Literature Monitoring # Safety Reporting # Local PV # Risk Management # Regulatory Intelligence # Quick Setup # Zero Admin Costs

What is AI-Driven Pharmacovigilance?

Artificial Intelligence Pharmacovigilance (AI-PV) combines advanced machine learning with a fully integrated digital platform to automate safety monitoring, case processing, and regulatory compliance. By unifying data from global sources, our solution covers the complete legal responsibilities in numerous countries — all centralised within one easy-to-use system.

Why Modernise PV?

  • Cost & Efficiency: Eliminate per-case fees and administrative overhead with predictable fixed rates.
  • Global Reach: Local PV experts and regulatory intelligence in many countries, set up in weeks.
AI PV Concept
Scenarios

AI Pharmacovigilance in Action

Deploy intelligent automation across the entire PV lifecycle.

Touchless Safety Reporting

Touchless Safety Reporting

From intake to authority submission — fully automated case processing with AI-assisted coding and narrative generation.

  • Individual Case Safety Reports (ICSRs)
  • Serious adverse event reporting for clinical trials
  • Fixed-rate pricing
Intelligent Literature Monitoring

Intelligent Literature Monitoring

Automated screening of vast global and local sources, with AI-driven case assessment and signal identification.

  • Full-text article retrieval
  • Real-time alerts
  • Cost-effective flat fee
Signal & Risk Management

Signal & Risk Management

Continuous data mining across safety databases to detect early signals and automate risk management plan updates.

  • Statistical signal detection
  • Ongoing risk assessment updates
  • Access to safety system master file 24/7
Expert PV Oversight

Expert PV Oversight

Highly qualified PV experts integrated with the digital platform — all key PV data available 24/7, including key safety documentation.

  • Single point of accountability
  • Automated metrics & audits
  • Seamless inspection support
Local PV Coverage

Local PV in Many Countries

Qualified local PV experts and regulatory intelligence for numerous jurisdictions, managed through a single dashboard.

  • Local language support
  • Country-specific compliance
  • Affordable local coverage
Clinical Trial PV

Clinical Trial PV

End-to-end safety reporting for clinical studies — from site to authority and back, fully integrated with the platform.

  • Serious adverse event reporting
  • Development safety update reports
  • Direct integration with clinical trial data systems
Platform

AI-PV Platform

Fully integrated pharmacovigilance system powered by human-machine collaboration.

Integrated PV System

The Integrated PV Core

A fully integrated PV system combining case processing, literature monitoring, signal detection, risk management, and local PV expert services in one digital environment. AI automates repetitive tasks while senior PV experts focus on scientific oversight.

  • Complete integration — no more siloed systems
  • Human-machine powerhouse: AI + expert oversight
  • 24/7 access to safety system master file, metrics, and audit trails

Automated Case Processing

AI extracts data from any source (email, standard electronic formats, PDF) and populates the safety database. Rules-based workflow routes cases for medical review only when needed — truly touchless processing.

  • Natural language processing for narratives
  • Auto-coding of drugs, events, and indications
  • Direct authority reporting (to health authorities worldwide)
Automated Case Processing
Global Compliance Dashboard

Global Compliance Dashboard

Real-time view of PV activities across many countries — submission status, local deadlines, and compliance metrics. Automated reminders and audit trails ensure high-level legal compliance.

  • Country-specific rules engine
  • Local PV expert task management
  • Inspection-ready documentation

Why Choose Our AI-PV Solution?

Redefining pharmacovigilance with transparency, speed, and intelligence.

Predictable Cost

No per-case charges. Simple fixed rates for safety reporting, literature monitoring, and local PV. All-inclusive packages available to suit your needs.

Global Reach, Fast Setup

Quick setup to cover your PV obligations globally. Local PV experts in numerous jurisdictions, fully managed through our platform.

Zero Admin Overhead

Automation eliminates manual data entry, duplicate workflows, and chasing paper. Your team focuses on strategic PV tasks while the platform handles the rest.

Workflow

How We Work Together

From initial consultation to full-scale PV operations — a seamless journey.

1

Consultation

We analyse your current PV footprint, target markets, and volume to design a tailored solution.

2

Platform Configuration

We set up our integrated platform for your organisation, integrating with your existing systems and defining rules.

3

Go Live & Automation

Within weeks, your global PV operations are live — cases flow, literature is screened, and signals are detected automatically.

4

Continuous Oversight

Your dedicated PV experts monitor the system, while you receive real-time dashboards and audit-ready reports.

Deliverables & Engagement Models

Flexible, transparent cooperation tailored to your needs.

What You Get

  • Fully Configured Platform: Your own instance with all modules activated.
  • Qualified PV Experts: Senior expert oversight included.
  • Local PV experts globally: Managed through the dashboard.
  • Automated Safety Reports: Regulatory authority submissions, narratives, and follow-ups.
  • Literature Alerts: Daily screening with AI case assessment.
  • Signal & Risk Reports: Periodic and ad-hoc analyses.
  • Inspection-Ready Documentation: Safety system master file, audit trails, and metrics.

Cooperation Models

  • Complete PV Service: All-inclusive fee covering all countries and modules.
  • Modular Services: Pick only what you need — safety reporting, literature monitoring, local PV with flexible modules.
  • FTE Augmentation: Dedicated PV experts working as an extension of your team.
  • Strategic Partnership: Joint development for innovative PV approaches.

Frequently Asked Questions

Common questions about AI-powered pharmacovigilance.

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