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Our Company

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

Integrating Clinical Operations and Pharmacovigilance for Safer Trials

Explore how stronger collaboration between Clinical Operations and Pharmacovigilance can improve safety oversight, reduce operational gaps and support safer, more efficient clinical trials.

Published: 17 June, 2026

Duration: 60 Mins

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News and Events

News

PrimeVigilance Continues Technology Investment to Strengthen Integrated MI and PV Services

Published 25 August 2026

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Events

WEBINAR: The Future of PV in the Era of Advancing AI Regulations

Published 7 September 2026

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24 August, 2026

From Limited Preparation Time to a Successful Regulatory Inspection

Insights Hub

When a regulatory inspection is announced, fragmented processes and documentation can quickly become significant compliance risks.

In this case, the client faced limited preparation time, inconsistent affiliate processes, fragmented documentation and restricted access to client systems. PrimeVigilance implemented a structured inspection-readiness program designed to rapidly align documentation, processes and teams while maintaining centralized oversight.

Key outcomes

Successful regulatory inspection
No major findings
Rapid closure of minor observations
Expanded responsibilities following increased client confidence

How Do You Build Inspection Readiness Under Time Pressure?

Download the case study to see how structured preparation, local and regional expertise, centralized oversight and rapid issue resolution supported a successful inspection.