Build the local PV foundation for global market access
Getting a therapy approved is only the start. To keep it available and grow it across markets, Marketing Authorization Holders (MAHs) have to meet each country’s local PV obligations consistently, across many jurisdictions at the same time, in an evolving regulatory environment.
Cencora connects global PV standards with local requirements, so safety never becomes the bottleneck to market entry or growth.
Cencora connects global PV standards with local requirements, so safety never becomes the bottleneck to market entry or growth.
Meet local obligations without slowing launch or growth
With expert local support that connects global pharmacovigilance standards to country-specific requirements, you can address the challenges that most often slow expansion.
Regulatory divergence
Regulations are diverse and constantly evolving across regions, with local safety requirements varying significantly from country to country.
Monitoring obligations
Tracking local medical literature and submitting case safety reports to national databases is resource-intensive, and gaps carry real consequences.
Safety demands
High-scrutiny products carry higher safety-management costs and obligations, adding further compliance complexity in every market where they are sold.
Dedicated PV expertise to support product growth
With more than 1,000 subject matter experts and native PV resources across 100+ countries, Cencora enables you to build a harmonized affiliate PV solution and strengthen communications across regions.
You can rely on experienced local staff to meet country-specific safety mandates, while centralization strategies deliver the scalability and efficiency needed to support your growth objectives.
You can rely on experienced local staff to meet country-specific safety mandates, while centralization strategies deliver the scalability and efficiency needed to support your growth objectives.
What we offer
Qualified person and leadership roles
QPPV, NCP, and LPPV support, including deputies, plus set-up and ongoing maintenance of local pharmacovigilance systems across your affiliate network.
Audits and inspection readiness
Local system audits, CAPA support, and inspection preparation, enabled by Smart Local Connect, our validated solution for automated oversight and KPI tracking.
ICSR management
Collection, triage, processing, and submission of individual case safety reports to national databases, supported by efficient and digitally enabled workflows.
Literature screening
Country-level medical literature surveillance powered by VIGILIT, our proprietary solution, helping you meet global and local literature obligations including EMA medical literature monitoring.
PV intelligence
Expert interpretation of country-specific requirements, with monitoring tailored to client needs and full traceability through our proprietary PSIQ system.
Broader affiliate coverage
Risk management plans, the PSMF, signal detection, risk-minimization measures, early access programs, PV agreements, and training for local staff.
Why choose Cencora for local affiliate PV management
In-market safety expertise
PV professionals in the markets you serve interpret local requirements and act as your safety contact with authorities.
One harmonized operating model
One partner and standardized processes across your affiliates replace a patchwork of local vendors and inconsistent safety practices.
Digitally enabled oversight
Validated, automated tools give you clear visibility into local compliance, deadlines, and performance across every affiliate market.
Expert insight
Outsourcing the local pharmacovigilance activities can help to reduce costs, give companies greater assurance that they are meeting their local PV obligations, and allow them to focus on other core activities.
— Alex Brenchat, Having the right local setup to comply with country pharmacovigilance obligations
Related solutions
PharmaLex is now Cencora
Local affiliate pharmacovigilance management is part of our Commercialization support capability. Same team, same expertise, now with greater reach.
Need more information about local affiliate PV management?
Our team of experts is here to assist you. Whether you have questions or need more detailed information, don’t hesitate to get in touch. We’re dedicated to providing the support you need.