About PrimeVigilance | PrimeVigilance (2024)

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US +1 (919) 792 3740
info@primevigilance.com

Our Company

About us

About PrimeVigilanceWhy PrimeVigilance?Executive Leadership TeamOperational Leadership TeamOur Mission, Core Values and VisionPrimeVigilance Corporate Social Responsibility StatementDownload PrimeVigilance BrochureDownload Ergomed Brochure

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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.

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.

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.

Learn more

Insights Hub

Latest Case Studies

Overview of the ISO Identification of Medicinal Products (IDMP) Standards

Published: 21 February, 2023

More case studies

Webinars

Latest Webinar

Exploring the Crucial Role of Local Persons for Pharmacovigilance on a Global Scale

The essential role of local person in ensuring effective pharmacovigilance worldwide

Published: 4 May, 2023

Duration: 19 Mins

More webinars

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News and Events

News

We offer end-to-end pharmacovigilance and vigilance services and solutions from clinical development to post-marketing

PrimeVigilance, an Ergomed Group company, was established in 2008 by Dr. Miroslav Reljanovic together with co-founder Dr. Elliot Brown. PrimeVigilance oﬀers holistic, top quality, cost-eﬀective, innovative clinical safety and PV services for pharmaceutical, biotechnology and medical device companies. Our leaders have an unrivalled reputation in the sector with a network of SMEs across the world. These include former senior regulators and consultants with expansive industry experience.

Ensuring a world with safer drugs

Our Mission, Core Values and Vision

We unlock the potential of vigilance and pharmacovigilance

We augment our domain expertise by integrating medical and scientific knowledge with regulatory science in clinical settings and in everyday practice. We identify previously unrecognized adverse effects or changes in their patterns to ascertain what action is necessary to optimize safe and effective use of medicines and medical devices. Our adaptable business models and integrative project management coupled with our flexibility as a partner, consistently fulfill our clients’ business requirements and safeguard their assets.

Operational Leadership Team

Meet the Team

We are a reliable partner recognized for the quality of our team, your pharmacovigilance thought partners

We bring together a team of 1000 professionals, located in 3 continents, whose skills, values and ingenuity make us unique in clinical safety and pharmacovigilance. We connect our clients to the right safety services and solutions. We specialize in helping emerging and established pharma and biotech companies comply with regulations, from developing PV systems right through to full management of safety operations. We are a partner who shares your commitment to patient safety and that purpose binds us all.

Contributing toward a better world

Our Corporate Social Responsibility

Thank you for such amazing support – we could not have done this without you! Your team’s dedication, quick turnaround, subject matter expertise, and kindness are to be recognized! Thanks for your continued commitments to quality.

Head Safety Processes Manager

Pharmaceutical Company

Discover how we can help you

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