Case complexity vs. case volume in pharmacovigilance
Our Vigilance Project & Compliance Manager Tina Kreiner experienced elephants and mosquitoes up close during her vacation in South Africa (including mosquito repellent!).
🐘 The elephant – representing a complex and medically challenging case that requires full attention.
🦟 The mosquitoes – representing countless standardized reports that nevertheless cannot be ignored.
The situation is similar in pharmacovigilance. Growing awareness and demanding regulatory requirements are increasingly leading to a higher volume of reports. At the same time, case reports more often concern complex issues (e.g., polypharmaceutical therapies, rare side effects, etc.).
In other words, sometimes it’s the elephant, sometimes it’s the 1,000 mosquitoes. Both take time, involve risks, and require smart prioritization, flexible processes, and targeted skills development.
Our tips for balancing the act:
✔️ Process and resource analysis
✔️ Flexible resource and outsourcing strategies
✔️ Workflow optimization (including automation potential such as AI tools)
✔️ Continuous training of the PV team
💬 How about you? Are you currently dealing with a thousand mosquitoes while taming an elephant at the same time?
We are happy to help – whether with strategies or directly with case processing.