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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.

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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

PrimeVigilance’s Effective Approach to New Region Expansion

Uncover how PrimeVigilance navigated the complexities of expanding Medical Information (MI) services into Japan, establishing a strong foundation in a new and challenging market.

Published: 7 November, 2024

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Webinars

Latest Webinar

The Regulatory Landscape of AI: The Current State and Future Trends

This session explores the critical role of regulatory compliance in AI development, deployment, and governance, highlighting strategies for balancing innovation with ethical and legal requirements. Join our expert speaker, Nikodem Latocha, as he provides actionable insights into navigating this dynamic landscape, ensuring your organization stays ahead of regulatory changes.

Published: 14 November, 2024

Duration: 40 Mins

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News and Events

News

Ergomed Group Announces Board Chair Transition

Published 7 April 2026

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Events

World Patient Safety Congress Europe 2026

Published 21 June 2026

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15 July, 2023

EMA Report on Pharmacovigilance Tasks (2019-2022)

Insights Hub

The EMA’s 2019-2022 report on pharmacovigilance (PV) tasks, published in June 2023, highlights the European regulatory network’s effective response to the Covid-19 pandemic, emphasizing preparedness, established PV tools, and collaborative innovation. The report details EMA’s progress in leveraging real-world evidence (RWE) through the Big Data Steering Group to advance treatment outcomes and expedite patient access.

This article covers key activities in pharmacovigilance, including PRAC efforts, adverse reaction reporting, and the modernization of EudraVigilance (EV) for improved data analysis. It also outlines forward-looking steps to enhance automation, expand real-world data use, and strengthen clinical engagement through initiatives like PRISMA, setting the stage for even more responsive PV in future public health challenges.