Transforming post-marketing safety operations

ICON partnered with a top 10 global pharmaceutical company to support its post-marketing pharmacovigilance (PV) operations. Over a multi-year engagement spanning more than seven years, ICON scaled its support across three distinct phases. The partnership evolved from a traditional service model into a fully embedded, strategic collaboration focused on continuous improvement, cost savings, and global harmonisation.

The client faced several challenges in managing its global PV operations: 

• Fragmented vendor landscape and inconsistent processes across regions  
• Rising operational costs and inefficiencies in case processing
• Limited automation and reliance on manual workflows
• Need for scalable solutions to support growing case volumes and regulatory demands

ICON implemented a phased approach to address the client’s evolving needs: 

• Stage I – Launch and transition: ICON initiated the partnership by integrating the sponsor’s existing PV workforce, converting client employees and contractors to supplement ICON’s team. A global team of 200 was built across multiple pharmacovigilance and safety functions, using an intelligent high-medium-low (HML) strategy to leverage low-cost regions for operational delivery, contributing to significant cost savings and improved turnaround times. This phase focused on establishing foundational processes, aligning operational models, and ensuring a smooth transition with minimal disruption.
• Stage II – Transformation and stabilisation: During this phase, ICON redesigned the delivery model, moving from a resource-based approach to a unitised structure that improved efficiency and predictability. This phase was guided by the sponsor’s goal to streamline operations and reduce costs, which was successfully achieved within three years. ICON ensured continuity and quality throughout, introducing process improvements and strengthening governance to support consistent global performance.
• Stage III – Innovation and optimisation: ICON invested in continuous improvement by adopting advanced PV technologies and automation tools. This included process optimisation, vendor consolidation, and seamless integration of newly acquired assets into the sponsor’s safety ecosystem.

ICON’s strategic approach delivered measurable results: 

• 43% reduction in case processing costs through automation and offshoring with 19% overall cost savings across PV operations
• Enhanced speed and accuracy in case handling and reporting
• Strengthened compliance and audit readiness through standardised processes
• Enhanced collaboration with high client satisfaction 

By combining deep pharmacovigilance expertise with cutting-edge technology and global delivery capabilities, ICON enabled the sponsor to transform its pharmacovigilance operations, achieve significant cost savings, and maintain high standards of quality and compliance.