Scaling a Global Pharmacovigilance Model for International Growth
QbD Group supported a family-owned pharmaceutical company in developing a scalable pharmacovigilance (PV) strategy to support international growth across Europe. By evaluating different operational models and defining a future-proof PV structure, the company improved efficiency, reduced operational workload and costs, and ensured continued regulatory compliance across multiple markets.
About the client
The client is a family-owned pharmaceutical company based in Spain with a growing international presence across Europe and other global markets.
Challenge
Developing a scalable pharmacovigilance strategy to support international expansion
As the company expanded its activities across France, Germany, Italy, Portugal, and Spain, it needed to scale its pharmacovigilance operations in a structured, compliant, and efficient way.
The existing PV setup required evaluation to ensure it could support increasing operational complexity, growing product portfolios, and higher case volumes while remaining aligned with global regulatory requirements and industry best practices.
The client also needed clarity on which operating model would provide the best balance between scalability, operational efficiency, implementation timelines, and long-term cost control.
Approach
Evaluating scalable PV operating models for sustainable growth
QbD Group developed a strategic framework to help the client identify the most future-proof pharmacovigilance operating model for its expanding international footprint.
Our approach included:
- Assessment of two operating models, full outsourcing and a hybrid PV model, through a scalability-focused lens.
- Collection and analysis of key operational inputs including products, countries, case volumes, medical inquiries, and complaints.
- Evaluation of the advantages, limitations, costs, implementation timelines, and milestones associated with each model.
- Simulation of scalability impact to assess long-term operational sustainability and growth readiness.
- Delivery of a tailored proposal outlining the recommended organizational structure, workflows, and required budget aligned with future expansion plans.
Throughout the project, QbD Group combined pharmacovigilance expertise with strategic operational planning to support informed decision-making and scalable growth.
Result
Establishing a scalable and cost-efficient PV framework
The project enabled the client to define a scalable pharmacovigilance model capable of supporting continued international growth while maintaining regulatory compliance.
As a result, the company achieved:
- A scalable PV operating model aligned with international regulatory requirements.
- A projected reduction in workload and operational costs of approximately 20%.
- Improved efficiency through process optimization, standardized workflows, and time-saving measures.
- Delivery of all supporting documentation and the proposed operating model within the planned timelines.
- Increased stakeholder confidence through QbD Group's demonstrated execution capabilities and pharmacovigilance legislative expertise.
The defined strategy now provides the organization with a robust foundation to scale its pharmacovigilance activities efficiently while supporting long-term international expansion.