ProPharma Group has launched a “Meet the Expert” series introducing you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to improve patient health and safety throughout the complete product lifecycle.
Meet the Expert: Tim Kolbrink, Pharmacovigilance Consultant
I work as a Pharmacovigilance (PV) consultant with a wide range of tasks e.g., acting as QPPV, providing PV trainings, case processing, and writing SOPs, procedures, and work instructions for our customers. As a QPPV, I am responsible for the whole pharmacovigilance system of a Marketing Authorization Holder. I write the Pharmacovigilance System Master File, which is a document that describes the client’s whole PV system. Another important task is performing the literature search for our clients. I select relevant articles related to a clients’ products for example on case reports or safety signals. I also take care of case processing. If an Adverse Event (AE) comes in, for example through one of our Medical Information centers, we add them to our database, or the clients’, and report it to relevant authorities. These are then used for Signal Management.
If it is not documented, it did not happen. You need evidence for your actions, especially for inspections and audits. For example, a literature search is mandatory on a weekly base. You need to capture in your processes that this is being done. Even if you don’t have any findings from your literature search in a certain week, you need to report on that as well. If a report from even one week is missing, it would be registered as a finding during an inspection. Every activity needs to be documented.
Each day at work is different as I work for several unique clients and have a truly diverse range of tasks. I am currently working at home during the COVID-19 pandemic but would normally be working from my local office in Leiden. Typically, I may be visiting a client to provide a Pharmacovigilance training to their staff, but during the pandemic, have shifted to performing these online. It’s been a new challenge, but I thoroughly enjoy connecting with my clients in this new virtual world.
I live together with my girlfriend and am a dad of a 2-year-old girl, who is my little angel. My passions are travelling (especially to Africa) and nature-photography. If you ever want to visit Africa, contact me! I can give you all the information you need, as I also worked there as a tour leader.
We have a very diverse team with a wide range of experience which can truly provide expertise across the whole spectrum of Pharmacovigilance activities. No matter the challenge you’re facing, our team can find a solution to help support it.
To connect with Tim and our complete team of PV experts, contact us today!
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Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
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ProPharma Group has launched a “Meet the Expert” series introducing you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to support...
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ProPharma Group has launched a “Meet the Expert” series to introduce you to our experts from around the world. This series will help you get to know who we are, and how our colleagues work to support...