iVigee » AI in Pharmacovigilance

∙ Currently deploying with a select group of pharmacovigilance teams

The First Agentic AI Pharmacovigilance Department

Higher quality. Faster outcomes. GxP validated. Lower cost.

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One

source of truth for every case, in every market

100%

of actions, human or AI, in one end-to-end audit trail

GxP

validated and inspection ready by design

Every market. Every authority. Local expertise on the ground.

AI IN PHARMACOVIGILANCE

Specialised agents working from one source of truth.

The iVigee Pharmacovigilance Agentic Ecosystem covers the entire pharmacovigilance system, built top-down, starting with AI governance integrated into the Quality Management System and PSMF.

Not software: a consultancy. We help you build your own AI-enabled PV system, tailored to your people and processes, so your team develops the AI literacy it will need for the future.

Rebuilding PV around what agentic AI makes possible.

Intake

Regulations

AI Agents

Rebuilding PV around what agentic AI makes possible.

Intake

Regulations

AI Agents

One connected ecosystem: physician-led, inspection-ready, fully managed

Diagram of iVigee’s agentic AI pharmacovigilance platform: safety cases from any source flow through AI agents for case processing, literature screening, QC and medical review into a central safety database, which feeds analytics, signal detection, electronic submissions and aggregate reports to regulators and partners worldwide.

See what this could look like for your team.

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RETURN ON INVESTMENT

The trade-off is over

Higher quality or lower cost?
Now you can have both

For as long as pharmacovigilance has been outsourced, offshored, or brought back in-house, one rule has held: higher quality costs more. iVigee has broken that rule. Every delivery model sits on the same curve: outsourcing, offshoring, hybrid models just move you along it, trading cost for quality.

See how it works

Illustrative. Every traditional delivery method trades cost for quality.

An agentic AI pharmacovigilance department is different

Costs fall below even the lowest-cost delivery locations, not just onshore teams, while quality improves across every output. Every action, human or AI, is captured in a single, end-to-end audit trail. Not a sample, every decision.

Why costs fall

AI agents absorb the high-volume work that used to require added headcount. A structural saving, not cheaper labour doing the same job.

Why quality rises

Decisions are challenged, not rubber-stamped. Agents surface evidence a single reviewer would miss and expose blind spots before they become errors.

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VALIDATION, OVERSIGHT AND QUALITY

Every agent governed like a PV professional

Fixed accountability tiers, one unified quality system with no exceptions for AI, and every workflow assessed against the same risk-based credibility framework regulators use for AI in drug safety.

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VALIDATION

Risk-based credibility assessment

Assessed per context of use, in line with FDA draft guidance, the EMA reflection paper and CIOMS WG XIV.

OVERSIGHT

Fixed accountability tiers

Accountability stays with named people. The autonomy of each workflow is a configuration choice, never a default.

QUALITY

One unified quality system

No exceptions for AI. Agents run inside the same QMS, SOPs, training and deviation and CAPA process as your people.

AI IN PV: INSIGHTS

Latest thinking on AI in PV

Regulatory thinking, practical guidance and a look at agentic PV in practice, from our experts.

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What Happens to Pharmacovigilance When AI Does the Work, video with Dr. Henry Seto and Dr. Jan Petracek

Questions answered

The use of AI, from machine learning to autonomous agents, to perform or support PV work: case intake and triage, duplicate detection, MedDRA coding, narrative drafting, literature screening, signal detection and reporting. In an agentic department, these agents operate inside the quality system under defined human oversight, not as external tools.

No. It changes what they do. Agents absorb high-volume routine work; qualified humans keep authority over causality, signal validation, expedited submissions and labelling decisions. Accountability stays with named people: the autonomy of each workflow is a configuration choice, never a default.

Yes, when it is built the way regulators describe: risk-based credibility assessment per context of use (FDA draft guidance), MAH responsibility for validating and monitoring AI (EMA reflection paper), and meaningful human oversight (CIOMS WG XIV). See how we validate and govern AI in PV. →

Intake, duplicate detection and data extraction automate well - across any channel, including reports from patients, social media or literature. Medical judgement, causality and seriousness assessment need a human with accountability.

Costs fall significantly compared with even the lowest-cost delivery locations, because the saving is structural: agents absorb volume that previously required headcount, not labour-rate arbitrage.

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Ready to transform your pharmacovigilance department?

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Tell us what you're working on, whatever the stage or market. We'll make sure your question reaches the specialist who leads that area, and that you get a real, considered answer back, not a brochure.