PrimeVigilance helps marketing authorization holders build a global PV Network designed for compliant local support, stronger governance, and greater consistency across markets.
With coverage in more than 160 countries and support for 500+ clients worldwide, PrimeVigilance provides the scale, structure, and expertise needed to support local pharmacovigilance compliance with greater confidence.
Speak With Our PV Network TeamOur PV Network at a Glance
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LCPPVs
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EU/UK QPPVs and Deputies
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countries covered
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clients globally
Moving Beyond Fragmented Local Pharmacovigilance Models
Local pharmacovigilance is often built one market at a time. Over time, that can create a patchwork of providers, variable execution, inconsistent communication, and reduced visibility at global level.
For MAHs, the challenge is not simply appointing a local pharmacovigilance contact. It is building a model that works consistently across countries, regions, and internal stakeholders.
A Global PV Network for Local Pharmacovigilance Compliance
PrimeVigilance provides a more connected alternative: a global PV Network built to support local compliance through broader direct coverage, regional leadership, and central governance.
A key differentiator of our network is the breadth of coverage delivered through PrimeVigilance employees and integrated regional teams. Strengthened through the acquisitions of Bloom and PhV LATAM, our model expands directly managed local coverage in key regions.
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More direct coverage through PrimeVigilance teams.
Through PrimeVigilance employees and integrated regional infrastructure — reducing fragmentation across local markets. Rather than relying on a patchwork of third-party local contacts, we extend our own operational reach into the markets where your products are approved.
Better quality and consistency across markets.
Consistent SOPs, training, and oversight across all markets — a uniform quality standard delivered through direct network alignment. Greater direct alignment reduces variability and strengthens your global compliance posture.
A network strengthened through strategic expansion.
The acquisitions of Bloom and PhV LATAM strengthen direct coverage in Europe and Latin America, reducing reliance on fragmented structures and delivering a more integrated and dependable local PV model.
Stronger governance with regional intelligence.
Central coordination combined with regional leadership and in-country expertise — maintaining stronger global control. Local knowledge is integrated into a governed framework rather than siloed within individual markets.
More than local representation.
Beyond formal LCPPV appointment — compliance readiness, PSMF maintenance, literature screening & regulatory advisory support. From appointment to active, strategic partnership that reduces operational risk and builds a more resilient framework.
Local PV Support for Different Operating Models
PrimeVigilance supports organizations at different stages of local pharmacovigilance maturity:
- Entering new markets and needs compliant local pharmacovigilance representation
- Reviewing an existing local PV provider network
- Managing multiple affiliates, vendors, or country-level PV contacts
- Looking to reduce fragmentation across regions
- Seeking stronger governance, escalation pathways, and visibility
- Building a more scalable local pharmacovigilance model
Flexible Local Pharmacovigilance Models to Fit Your Organization
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For organizations with established affiliates that need targeted support to fill gaps in local capacity or coverage.
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A shared model that strengthens your existing local setup with additional resource, governance, and quality oversight.
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A fully managed multi-country model for organizations looking to consolidate, streamline, and outsource local PV operations end to end.
From Local Obligation to Global Advantage
Many health authorities require marketing authorization holders to appoint a local pharmacovigilance contact or equivalent local representative. But the real challenge is not simply assigning a role. It is creating a model that works consistently across markets while integrating local pharmacovigilance into a more connected global framework.
With broader employee-based coverage, integrated regional support, and centralized governance, our PV Network helps transform local compliance into a stronger operational advantage.
Local Pharmacovigilance Services
Our PV Network supports a wide range of local pharmacovigilance requirements and operating models:
ICSR intake and processing, including unblinding for regulatory reporting
Explore Case Processing Services →Local submissions and regulatory advice across complex procedural scenarios
Explore MAA Services →Fulfilment of local PV requirements in relevant procedures and systems, such as PSMFs
Explore Case Processing Services →PV/product-specific training and support with local literature screening activities
Explore Literature Surveillance Services →Direct access to strategic advisors and SMEs, including PVExpert™
Explore Project Management Services →Additional services are available.
See Sell Sheet for Full Scope →See How PrimeVigilance Supports Local PV Complexity
Inspection Facilitation Without Local MAH Presence
This PrimeVigilance case study shows how local PV experts and centralized oversight enabled smooth inspections, full compliance, and consistent outcomes without requiring local MAH offices.
Urgent Compliance Recovery Following Vendor Transition
This PrimeVigilance case study shows how rapid local action and structured remediation restored compliance, protected the national licence, and stabilized operations in a high-risk period.
Frequently Asked Questions
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