Medical Information and AE Reporting: The First Line of Pharmacovigilance
As Joanna Kotwica writes in her blog, Medical Information is more than a support function—it’s the frontline of pharmacovigilance, ensuring patient safety through accurate, compliant communication
13.6.2025
The primary role of Medical Information is to ensure that accurate, up-to-date, and unbiased data about medicinal products is readily available. This service is not only essential for patient safety and professional guidance but is also a regulatory requirement. Marketing authorization holders must establish a scientific service responsible for disseminating information on medicinal products placed on the market.
In the pharmaceutical industry, medical information services play a vital role in ensuring both regulatory compliance and patient safety. While it may seem like a customer service function at first glance, medical information is much more than simply answering inquiries—it is a highly specialized field that requires accuracy, adherence to approved materials, and a deep understanding of pharmacovigilance (PV) processes.
The Importance of First Intake in AE Reporting
When a healthcare professional or patient contacts our medical information service team with a potential adverse event, that first interaction sets the foundation for everything that follows. If key details are missed or misinterpreted, it can impact the entire reporting process. The challenge is not just to document what is said but to ask the right questions, clarify uncertainties, and ensure that all relevant information is collected without influencing the caller’s account.
Over the years, I’ve seen how the ability to assess a case and ask precise follow-up questions evolves with experience. For those new to medical information, it’s crucial to receive support from senior colleagues. This guidance helps them develop the skills to ensure reports contain all necessary information from the start, reducing the need for additional follow-ups. It streamlines the process for both pharmaceutical companies and regulatory authorities and highlights the importance of mentorship in building expertise.
Accuracy Over Assumptions
A common misconception is that medical information is just another form of customer service. In reality, we are bound by strict guidelines, ensuring that every response is based on approved sources like the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL). A misinterpretation or an assumption can have serious consequences—not just in terms of compliance, but for patient safety as well.
There is also the balance between capturing data for pharmacovigilance and providing accurate information to the person on the other end of the line. When a patient contacts us, it is usually because they have a question or concern about their medicinal product. During these conversations, we may identify a potential adverse event and navigating these conversations while ensuring regulatory compliance is a key part of what we do.
Ensuring Compliance Through Continuous Training
To ensure our team is well-equipped for this responsibility, we undergo regular training sessions focused on pharmacovigilance requirements and best practices. These trainings keep us updated on evolving regulations and reinforce our understanding of how AE reports are processed once they are sent to the Marketing Authorization Holder (MAH). By having this deeper knowledge, medical information officers can provide more informed support, ensuring that reports are handled efficiently and in line with regulatory expectations.
Final Thoughts
Pharmacovigilance is complex, but at its core, it is about patient safety. Having worked in medical information for years, I know that our role in PV is far more than just answering inquiries—it is about safeguarding patients and ensuring that pharmaceutical companies uphold the highest standards of patient safety.
Joanna Kotwica, Team Lead, Medical Information