iVigee

What iVigee does

iVigee is a physician-led pharmacovigilance services company founded in 2021 and headquartered in Prague, Czech Republic, with a US subsidiary in Burlington, Massachusetts. The firm delivers outsourced pharmacovigilance (PV) operations, strategic PV consultancy, and PV technology services to pharmaceutical and biotechnology companies worldwide. Its core offerings span the full PV lifecycle including case processing (ICSR), signal management, risk management, QPPV and local QPPV coverage, regulatory intelligence, clinical safety, vendor oversight, GVP audit readiness, training, and complete outsourced PV department delivery. The company is led by physicians with direct regulatory authority experience, most notably Dr. Jan Petracek (former Head of Risk Management at the European Medicines Agency and contributor to ICH and CIOMS guidelines), and includes alumni of Vertex, Moderna, Glenmark, and Parexel.

The technology stack centers on deep Oracle Argus Safety specialization (implementation, configuration, E2B(R3) gateway setup, migrations, managed services, and Azure-hosted environments) augmented by proprietary platforms: iViReg (regulatory intelligence and impact assessment), iViNet (partner data exchange), iViSight (analytics and signal detection dashboards), and iViSignal (quantitative signal detection). The company integrates with EudraVigilance, FAERS, and VigiBase for signal augmentation, and uses AI-assisted screening in case processing and literature monitoring. A global network of local PV experts covers 120+ countries for local regulatory representation.

Commercially, iVigee operates a direct enterprise sales motion with quote-based pricing tailored to client stage and scope. Entry-point subscription packages (PV Foundations Pack for early-stage companies and MAH Compliance Pack for marketing authorization holders) feed into full outsourcing engagements. Revenue is generated through managed services, professional services, and subscription streams. The firm holds ISO 27001 certification, positions on a "no critical findings" quality guarantee, and emphasizes thought-leadership marketing via a weekly PV newsletter, regulatory video updates, and a knowledge hub. The company is privately held, physician-founded, and explicitly positions itself as "led by physicians, not financiers" with no disclosed external funding.

Name

iVigee

Legal name

iVigee Services, a.s.

Website

https://ivigee.com

Company type

Private

Founded year

2021

Operating status

Operating

Headcount range

1–10 employees

Short description

iVigee is a physician-led pharmacovigilance services provider founded in 2021 and headquartered in Prague, delivering outsourced PV operations, consultancy, and Oracle Argus-based technology solutions to pharmaceutical and biotechnology companies across 120+ countries.

Ownership category

akta.pro rank

Product category

Pharmacovigilance Services

NAICS

Pharmacy Benefit Management and Other Third Party Administration of Insurance and Pension Funds (524292)

akta.pro primary industry

Pharmacovigilance, Drug Safety & Risk Management FSP (HLAGAOAF)

akta.pro secondary industries

Signal Detection & Safety Analytics (Epidemiology/RWE) (HLAGALAC), PBM Technology Platforms (ePA/eRx/Real-Time Benefit Tools) (HLAEAKAL)

Keywords

• Pharmacovigilance outsourcing
• Drug safety services
• PV consulting
• Signal management
• Safety database implementation

Headquarters

HQ city

Prague

HQ country

Czechia

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Pharmacovigilance Outsourcing Services: Complete, managed pharmacovigilance solutions delivered as an outsourced department extension. Covers all PV functions including case processing, signal management, QPPV services, regulatory intelligence, and quality management.
2. Pharmacovigilance Consultancy: Expert assessment and strategic advisory services. Physicians and scientists assess PV systems, advise on changes needed, and deliver actionable plans.
3. Pharmacovigilance Staffing: Placement of qualified PV professionals including interim Heads of Safety, QPPVs, regional leads, safety physicians, and technology specialists.
4. Vendor Management Services: Independent vendor oversight, qualification, audit services, and performance tracking for PV vendor ecosystems.
5. Technology Services: Oracle Argus implementation, configuration, managed services, hosting, migrations, integrations, and validation services.
6. Training Services: PV training programs covering GVP legislation, AI in PV, audit readiness, and inspection preparation.

Pricing tiers

Go-to-market motion2 records

Distribution channels1 record

Marketing channels6 records

Core offering

iVigee delivers physician-led pharmacovigilance solutions to pharmaceutical and biotech companies worldwide. Its core offerings include outsourced PV departments (Instant PV Department), expert consultancy, qualified PV staffing, Oracle Argus Safety implementation and managed services, and proprietary technology platforms (iViReg, iViNet, iViSight, iViSignal) covering regulatory intelligence, signal detection, risk management, ICSR processing, QPPV services, and AI transformation.

Product overview

iVigee is a physician-led pharmacovigilance solutions provider offering a comprehensive portfolio of services organized around three pillars: (1) Pharmacovigilance Services — an integrated suite covering outsourcing (Instant PV Department), staffing, vendor management, ICSR processing, GVP audit readiness, regulatory intelligence, clinical/medical safety, QPPV services, Local QPPV network, signal management, risk management, training, and AI transformation; (2) Pharmacovigilance Consultancy — strategic advisory engagements with individual experts including Dr. Jan Petracek, Dr. Henry Seto, Dr. Marcela Fialova, Vijeet Goel, and Dr. Natalia Kalousova; and (3) Pharmacovigilance Technology — comprising Oracle Argus implementation and maintenance, managed services with Azure cloud hosting, and proprietary technology modules including iViReg (regulatory intelligence), iViNet (partner data exchange), iViSight (analytics and signal detection), and migration/integration services. The technology stack also supports a proprietary signal detection capability called iViSignal for quantitative analysis. The company positions itself as inspection-ready by design with a no-critical-findings guarantee.

Differentiator

Problem solved

Functional benefit

Products and services

• Pharmacovigilance Outsourcing (Instant PV Department) Complete, physician-led pharmacovigilance department delivered as an outsourced operation covering every critical function including case processing, signal management, regulatory intelligence, technology, medical review, risk management, quality, literature monitoring, and aggregate reporting.
• Pharmacovigilance Staffing On-demand placement of qualified PV professionals including interim Heads of Safety, Regional PV Leads, PV Systems Experts, QPPVs, Safety Physicians, and FSP resourcing models for scalable embedded support.
• Vendor Management Independent vendor oversight services including advisory on tools and service providers, performance tracking, centralized governance, vendor qualification, audits, and clinical trial vendor management.
• ICSR Processing End-to-end Individual Case Safety Report processing including intake solutions, case processing, aggregate reports (DSURs, PSURs, PBRERs, PADERs), safety oversight, medical review, and deadline-driven case submission.
• GVP Audit Readiness and Quality Management Quality management services covering SOP development and maintenance, PSMF creation and upkeep, audits and inspection support, CAPA development, and continuous quality oversight across PV operations.
• Regulatory Intelligence PV regulatory intelligence tracking across global markets with impact assessments, tailored news feeds, and knowledge management for safety requirements, delivered through the iViReg platform.
• Clinical and Medical Safety Clinical safety support including trial safety monitoring and reporting, protocol development and review, and medical safety expertise for development and post-market products.
• QPPV Services UK/EU QPPV appointment, regulatory accountability, and continuity support including transition management when personnel or organizational changes arise.
• Local QPPV Network Qualified local responsible persons in multiple countries providing single-point-of-contact coverage for national authorities, local case intake and follow-up, inspection readiness, and aRMM support.
• Signal Management Complete signal management process including detection using analytics and AI, augmentation across internal and external data sources, medical and statistical validation, communication, and full audit trail documentation.
• Risk Management RMP development and lifecycle management, aRMM design, execution, and effectiveness evaluation, and end-to-end risk system setup and oversight.
• Pharmacovigilance Training Training programs covering GVP legislation and module training, in-house customized PV training, GVP auditor training, AI in PV masterclass, professional certification pathways, and audit and inspection readiness training.
• AI Transformation AI strategy, implementation, and governance services covering AI literacy training, implementation in case processing/signals/reporting, strategic roadmap design, and GxP validation support for AI systems.
• Pharmacovigilance Consultancy Expert assessment and strategic advice covering PV system strategy, signal and risk management, AI guidance, EU QPPV oversight, inspection and crisis management, and transition management.
• Pharmacovigilance Technology (Oracle Argus Implementation, Managed Services, Migrations, and Proprietary Platforms) Implementation, configuration, validation, managed services and Azure hosting of Oracle Argus Safety, plus proprietary platforms iViReg (regulatory intelligence), iViNet (partner data exchange), and iViSight (analytics and signal detection), with migrations, integrations, and E2B(R3) gateway setup.

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration4 records

AI capability7 records

Feature5 records

Partnerships

One partnership is on record.

• OraclecoreTechnology or IntegrationiVigee specializes in Oracle Argus Safety database implementation, configuration, validation, managed services, and optimization. The partnership involves deep technical expertise in Argus architecture, E2B gateway setup, and system configuration for pharma and biotech clients.

Scale indicators3 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• PrimeVigilance: Specialist pharmacovigilance services provider (now part of Ergomed/QPS) offering case processing, signal management, QPPV, and regulatory intelligence — directly comparable in scope to iVigee's PV outsourcing and consultancy.
• PharmaLex: Regulatory affairs and pharmacovigilance services firm covering QPPV, signal detection, risk management, and safety database support — competing in iVigee's exact PV outsourcing and consultancy space.
• Arriello: EU-based pharmacovigilance, regulatory affairs, and quality/Compliance services provider for pharma and biotech, with QPPV and local-PV coverage comparable to iVigee's offering.
• ProPharma Group: Life sciences consulting and PV services provider offering pharmacovigilance, regulatory affairs, and quality/compliance support to pharma and biotech sponsors — overlapping iVigee's consultancy and managed services.

Broad incumbents

• IQVIA: Largest global CRO offering comprehensive pharmacovigilance, safety database, signal management, and QPPV services as part of a broader clinical and commercial portfolio — incumbent competitor for enterprise PV outsourcing RFPs.
• Parexel: Global CRO with dedicated pharmacovigilance and safety services practice; competes with iVigee for biotech and pharma safety outsourcing work at larger scale.
• ICON plc: Major CRO with full pharmacovigilance and post-marketing safety offerings, competing for multi-region enterprise PV mandates.
• Fortrea (Labcorp Drug Development spinoff): Clinical and safety services provider (post-Labcorp spinoff) offering PV, signal detection, and safety database services to pharma/biotech sponsors.

Emerging players

• Veeva Systems: Cloud-native life sciences software provider with Vault Safety as a direct alternative to Oracle Argus; competes with iVigee's technology services and partner ecosystem.
• ArisGlobal: Life sciences R&D technology vendor with LifeSphere Safety platform competing against Oracle Argus in iVigee's core technology services wedge.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about iVigee