Our client, a top 5 global pharma company headquartered in the USA, had been experiencing years of sustained growth. With this growth came increased complexity in managing their global operations particularly in the realm of pharmacovigilance (PV). Local PV resources, often fragmented and reporting to local medical directors or general managers, faced increasing challenges due to evolving regulatory demands and the company’s rapid expansion. The decentralized nature of their affiliate PV model presented significant risks, including inconsistent implementation of processes, limited global oversight, and exposure to potential audit and inspection findings.

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