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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

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.

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

Navigating the Latest Revisions in GVP: Key Updates on Module XVI and Risk Minimization Measures

Published 24 September 2024

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Events

DIA Global Pharmacovigilance and Risk Management Strategies Conference 2025

Published 30 December 2024

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19 October, 2020

The Importance of a Full Understanding of the Pharmacovigilance System Master File (PSMF) Within and Outside EU

Insights Hub

A comprehensive understanding of the Pharmacovigilance System Master File (PSMF) is crucial for pharmaceutical companies navigating compliance within the EU and beyond.

This session provides an in-depth look at the PSMF, examining both EU-specific requirements and the unique challenges of maintaining pharmacovigilance systems in non-EU regions. Dr. Marcela Fialova and Dr. Jana Hyankova will guide attendees through the various elements of PSMF setup and maintenance, highlighting the importance of consistency across global PV systems and exploring the different types of PSMFs applicable to respective regulatory frameworks.

Led by experienced pharmacovigilance experts, this session is tailored for PV professionals, regulatory teams, and quality assurance managers seeking to optimize PSMF practices and ensure regulatory compliance across multiple regions.

Key Takeaways Include:

Detailed overview of the PSMF setup and maintenance requirements for global pharma companies
Insights into EU-specific PSMF types and their compliance implications
Key considerations for establishing PV system descriptions in non-EU regions
Strategies for maintaining consistency across multiple PSMFs and PV system descriptions