Discover how QbD Group improved pharmacovigilance for a global leader in biotechnology, ensuring regulatory compliance and patient safety.
A global leader in biotechnology, specializing in the discovery, development, and delivery of innovative therapies for neurological diseases, rare genetic disorders, and autoimmune conditions. To enhance its pharmacovigilance (PV) activities within the Iberia Cluster, encompassing both Portugal and Spain, the company has enlisted our team. QbD Group will provide comprehensive PV services for the company’s affiliates in these regions, leveraging our expertise in local regulatory requirements and language-specific skills to ensure the highest standards of patient safety and regulatory compliance.
One of the key challenges faced was overcoming past difficulties related to high staff turnover, which significantly impacted the quality of PV activities. This instability made it challenging to maintain consistency and meet the stringent KPIs and metrics required for regulatory compliance.
Our approach to enhancing the company’s pharmacovigilance activities involves comprehensive case and follow-up management, reconciliation with numerous client partners, and thorough literature searches. We will generate monthly reports, manage KPIs and metrics, and perform LCPPV and/or deputy LCPPV activities for both Spain and Portugal.
This long-term solution, initially spanning three years, ensures continuity of all activities, supported by our native language profiles. We will implement LCPPV (deputy) roles and maintain a close relationship with the company’s team leads to build strong confidence and a focus on quality.
The results of our collaboration have been very positive. KPIs and work quality have shown continuous improvement, addressing and mitigating turnover rate issues.
The company has provided positive feedback on our services, highlighting that the value and service delivered met their high expectations. This has fostered a strong sense of confidence and trust in Azierta, part of the QbD Group, as a privileged partner.
Driven by our own belief in the project, we still provide guidance and advice whenever needed. We do not only lay out the roadmap, we are involved in the journey as well.
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