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.
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.
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.
Dr. Niteen, a Project Lead at Syntel has total of 9+ years’ experience in Clinical Safety and Health Care. He has long standing experience in end-to-end Drug Safety/Pharmacovigilance activities from Case Receipt, Data Entry, Quality Review, Submissions and Quality Assurance in the Pharmacovigilance domain along with Aggregate Report Writing (PADERs & PSURs). Prior to Pharmacovigilance domain, he was into clinical practice & hospital patient management for 3 years.
