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PV Outsourcing

Decide These Four Things Before Your PV Vendor RFP

Before you send a PV vendor RFP, settle the scope, sourcing split, guardrails and ownership. A guide for Heads of Safety and EU-QPPVs replacing a provider.

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Governance

You appointed a QPPV. The responsibility stayed with you.

Under EU law, the QPPV takes over pharmacovigilance tasks while resources, oversight and audits stay with management. In small and mid-sized companies, this usually surfaces at an inspection or an acquisition.

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PV System Development

A Blueprint for Overwhelmed Safety Leaders

Rapid expansion through acquisition or market entry is a significant risk factor for pharmacovigilance (PV) systems in small and medium-sized enterprises.

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Three healthcare workers in scrubs taking a break and talking in a sunlit hospital hallway with large windows.
Modern office building facade with large windows featuring vertical panels in shades of orange, yellow, and brown, with autumn-colored trees and tall dry grasses in the foreground.
Spiral staircase in a bright, modern building
Modern office building with large glass windows reflecting its interior, showing orange letters spelling MAFINEX.
Woman with curly hair wearing business attire, leaning on a glass balcony and looking up while holding a smartphone with both hands in a modern building with white structural beams.
Medical team walking along a glass corridor in a hospital
Modern office workstation in a clinical research facility
Two healthcare professionals talking on a glass balcony in a modern hospital
Three healthcare workers in scrubs taking a break and talking in a sunlit hospital hallway with large windows.
Modern office building with large glass windows reflecting its interior, showing orange letters spelling MAFINEX.