Factory based Operational Model for Pharmacovigilance

The rapidly evolving Pharmacovigilance (PV) industry is opening up to outsourcing. However, the business drivers for outsourcing have changed. They are now looking to outsource core activities such as signal detection, risk management, etc.

Pharmaceutical companies need to strike a balance between effective management, high quality standards, 100% regulatory compliance and efficient innovations while considering outsourcing for PV activities. For this the pharmaceutical companies need to transform their operational strategies to PV management.

Currently PV teams are set up based on the core activities and simultaneous utilization of resources across functions. However, multi-tasking divides attention, adversely affecting the productivity. Diverse conventions across these activities increase the chance of errors, impacting the quality of cases. Flexible resource utilization challenges case-level tracking, leading to complexity in workflow management. The chances of missing a reportable case increases in this multifaceted scenario.

Pharmacovigilance Current Practice

Factory-based operational model deploys a team of specialists, handling distinct activities following an assembly line. Assembly lines are designed to suit client requirements, e.g. product line, case types, etc. It offers high clarity on the task for each resource, enabling a focused approach leading to reduced turn-around time, while maintaining high quality. All cases are processed within five days with 100% regulatory submission compliance to applicable regulatory authorities such as US-FDA, MHRA, Health Canada, etc. as opposed to 80% in 15 days. This simplified process eases workflow management along with shortened case-processing timelines and increased scope for innovation.

Pharmacovigilance Factory Model

Traditional Operational Model

Factory-based Operational Model

Flexible/varied work assignments per resource Assembly line with distinctive assignments
All types of cases assigned to same teams devised based on activities Different assembly lines formed based on case type, product type and regulatory group
Codependent and multifaceted work assignment adversely impacts efficiency Streamlined process and independent teams lead to concentrated efforts increasing daily case output
Difficult to oblige to diverse conventions for varied cases, adversely influencing quality Ease in adhering  to conventions, improving  quality
Trend analysis and process improvisation is a challenge Simplified process and distinct team structure facilitates trend analysis and collating feedback
Complex Workflow Management, impacting regulatory compliance Linear Workflow Management, yielding 100% adherence to regulatory timelines

Going forward, the factory model will help Pharmaceutical companies to achieve hassle free Pharmacovigilance operations, while adhering to stringent regulatory mandates.