Optimizing Pharmacovigilance for a Biotechnology Leader
Boosting Pharmacovigilance in the Iberia Cluster
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.
Tackling Staff Turnover
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.
Sounds familiar? We can help.
Improving Pharmacovigilance:
Comprehensive Management & Long-Term Support
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.
Achieving Positive Results Through Quality and Trust
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.
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