- Ingelise Bærentzen Melchiorsen, Head of Drug Safety, NNIT
Drug safety departments are often seen as a cost center. This perception minimizes the value of drug safety operations and by repeating it, organizations are missing out on an abundance of opportunities for optimization and ultimately business acceleration.
Regulatory requirements are on the rise and ICSRs (Individual Case Safety Reports) are rising exponentially. The drug safety department has never been busier, and the case workflow is complicated by constant new regulations imposed. We suggest ways that life sciences teams can gain added value and hopefully encourages a new perspective on drug safety and pharmacovigilance.
An important knowledge center that requires attention
The drug safety department is a knowledge center. It possesses information on the latest benefit risk ratio, real world evidence on the use and compliance of your products, contraindications, comorbidities, and much more.
- When PV and Drug Safety continues to be seen as a cost center, it minimizes the value of the department and the opportunities for optimization and business acceleration, says Ingelise Bærentzen Melchiorsen, Head of Drug Safety at NNIT.
This knowledge is currently being used with only health authority reporting and compliance in mind and is being locked away due to huge workloads and regulatory requirements, but it has much greater potential than that. Insights based on this knowledge should be shared across business units and sections in the pharmaceutical company, as these insights can optimize the work done across departments.
With moderate investments, it is possible to both optimize the tasks in the drug safety department, while leveraging the wealth of knowledge to be shared and utilized across the rest of the organization. The result is empowering the business to work smarter and stay efficient, even though the workload increases exponentially.
- The drug safety department is not just a crucial knowledge center, but also a catalyst for positive change. By harnessing the power of shared information across organizations, we have the potential to empower drug safety organizations and drive significant improvements in business outcomes. In industries where the quality of life is at play, our collective efforts can make a profound difference in ensuring the safety and well-being of patients worldwide, says Ingelise Bærentzen Melchiorsen.