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About us

About PrimeVigilance Why PrimeVigilance? Executive Leadership Team Operational Leadership Team Our Mission, Core Values and Vision PrimeVigilance Corporate Social Responsibility Statement Download PrimeVigilance Brochure Download Ergomed Brochure

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Ergomed Group Sites

Ergomed Corporate Site Ergomed Clinical Research Site

Services

End-to-end services for high-quality safety and pharmacovigilance operations

Benefit-Risk Management

Case Processing

Safety Systems and Reporting

QPPV and PSMF

Local Contact Person for Pharmacovigilance

GVP Audits/Inspection Preparedness

Medical Information Services

Safety and Medical Writing

Literature Surveillance

Signal Management

Pharmacoepidemiology

Medical Monitoring

Clinical Trial Safety Committee Management

Marketing Authorization Applications

Safety Management Plan

Project Management

Services Homepage

Solutions

Technology-driven solutions integrated into the pharmacovigilance landscape

PVConsult™

Optimise your PV operations through monitoring and use of technology by our SMEs.

PVTransition™

Come to rescue of your PV systems during service provider modifications or technology switch.

PVBridge™

Help our long-standing clients to develop in-house pharmacovigilance capacity.

PVIntegrate™

Streamline your PV systems and processes during expansion.

PVExpert™

Strengthen your negotiations with regulators, HTAs and external stakeholders.

See all Solutions

Product Expertise

Product expertise which enables efficiencies in PV operations

Innovative/Brand Products

Support the development of PV plans and risk minimization measures pre- and post-marketing.

Generics, Hybrids, Biosimilars

Methodical management of challenging PV agreements, signal detection, audits schedules & conduct and training.

Vaccines

Comprehensive PV management of seasonal vaccines ICSRs and systems to enable seamless end-to-end operations.

CGT/ATMP Services

Providing specialized and comprehensive support to organizations navigating this complex field.

Devices and Combination Products

Our experts can advise you on your vigilance system, post-market surveillance and safety reporting.

Pediatric Medicines

Support tailored PV research in pediatrics and draw lessons from risk minimization of ARs in adult population.

Medicines for Older People

We adjust your RMPs cognizant that co-morbidities or side effects - specific to older patients - will shape PV activities.

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Insights Hub

Latest Case Study

Global Pharmacovigilance Transformation Through Vendor Consolidation and Strategic Partnership

Discover how PrimeVigilance consolidated approximately 70 local vendors into one strategic partnership, creating greater visibility, standardized processes and centralized governance across a complex global PV network.

Published: 24 August, 2026

More case studies

Webinars

Latest Webinar

Scaling Pharmacovigilance: From Clinical Development to Commercialization

Explore how to assess readiness, strengthen oversight and build an operating model that can support commercialization and global expansion.

Published: 7 October, 2026

Duration: 60 Mins

More webinars

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News and Events

News

Ergomed Group announces the appointment of Jovan Willford as CEO. Start date November 2nd.

Published 14 October 2026

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Events

WEBINAR: Turning Global Regulatory Requirements into Compliant Local Action

Published 20 October 2026

View all Events

See all News and Events

27 October, 2026

The Future of PV in the Era of Advancing AI Regulations: What QPPVs Need to Know

Insights Hub

As artificial intelligence becomes increasingly embedded in pharmacovigilance, how can QPPVs and safety leaders navigate evolving regulatory expectations while maintaining effective oversight?

In this on demand webinar, presented by PrimeVigilance in collaboration with DIA, Jana D’Alascio and Nikodem Latocha explore AI adoption across PV workflows, the regulatory developments shaping its use, and the implications for governance and accountability.

What you will learn:

Practical approaches to establish AI governance boundaries that maintain QPPV accountability
Implementable strategies to align PV quality systems with the EU AI Act and pharma-specific regulations
Insight into how Safety Leaders can proactively lead the transformation of pharmacovigilance operations
Strategies to maintain inspection-ready AI governance through robust documentation, oversight and QPPV accountability

Expert Speaker

Jana D'Alascio

Senior Director, QPPV

Nikodem Latocha

Associate Director, Quality

Watch recording & get slides

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