Rapid Stabilization of Multi-Country Local Affiliate PV Operations.
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Summary.
A global pharmaceutical company with an established EU footprint faced increasing pressure to maintain compliant local pharmacovigilance (PV) activities across multiple countries. Local affiliate responsibilities – including safety reporting, authority interactions, and literature monitoring – were being handled inconsistently, with varying levels of oversight.
This created operational risk, particularly given the need for local Qualified Persons / Safety Officers and direct health authority engagement in several markets.
Our expert team was requested to:
- Conduct a comprehensive assessment of existing local affiliate PV activities.
- Provide a scalable and compliant operating model to support local PV obligations.
- Deliver greater visibility, governance, and control across all participating countries.
Our objective was not only to address immediate compliance risks but also to establish a sustainable framework capable of supporting future growth and regulatory complexity.
Challenges.
- Fragmented local affiliate model across multiple vendors and internal teams.
- Inconsistent compliance with country-specific safety requirements.
- Limited visibility at a central level of local PV performance.
- Increasing inspection readiness concerns.
As seen across the industry, these decentralized affiliate structures often lead to variability in compliance and significant oversight burden on central teams.
Solution.
We assembled a dedicated global PV team, while providing the client with a single point of contact.
Arriello deployed a centralized-but-local hybrid model, combining:
- A global PV network covering 150+ countries, using trained local representatives operating under a unified QMS;
- Standardized processes for:
- Local case intake and reporting;
- Authority communications;
- Literature monitoring and follow-up;
- Dedicated PV network management to ensure:
- Consistent training and performance oversight;
- Clear escalation pathways;
- Central reporting and metrics tracking.
We fully integrated local resources into a single governance structure, ensuring consistency across all territories.
Our solution brought the following outcome:
- Local resources were fully integrated into a single governance structure, ensuring consistency across all territories.
- Improved compliance consistency and inspection readiness.
- Clear global visibility of local activities and risks.
- Reduced operational burden on central PV teams.
Our Holistic Approach.
This case demonstrates the value of treating local affiliates as an integrated system, not standalone entities – a recurring issue for large MAHs operating across Europe and globally.
Arriello’s commitment begins with your first contact, focusing on building a partnership. Our integrated services in PV, quality and compliance, and regulatory affairs ensure a seamless collaboration that adapts to the evolving needs of your pharmacovigilance system.
Need support stabilizing your local PV operations?
Contact Arriello to discuss how our global PV network can help strengthen compliance and oversight.
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