Career Recruitment Site

To Deliver the Value of
Safety to Patients

PV Case Management 1, PV Operations, Pharmacovigilance Kohei Yamashita

Developing an interest in drug safety at university

I developed an interest in healthcare when I was admitted to a hospital for surgery as a primary school student. I realized the power of pharmaceutical products from that experience and decided to study pharmacy at university as I wanted to help patients suffering from diseases through medicines. During my studies, I gradually developed an interest in the safety aspects of drugs and decided to conduct research on the safety of pharmaceutical products.

Through university lectures and practical training in pharmacy and Hospital, I learned the risks and benefits of pharmaceutical products, the importance of the balance between the two, and that information on safety is imperative for understanding the risks. I chose to join Astellas because the company specializes in developing new drugs and continuously delivers new medicines to patients around the world. I was also drawn to the fact that the company places great importance on earning society's trust and considers safety to be the top priority. Such qualities were consistent with my goal to contribute to guaranteeing the continuous safety of pharmaceutical products.

The fortress of pharmaceuticals is to maintain and improve reliability

Astellas’ Raison D'être is “Contribute toward improving the health of people around the world through the provision of innovative and reliable pharmaceutical products”. The Pharmacovigilance Department plays a huge role in the reliability of our medicines. We ensure patient safety by liaising with the regulating authorities in each country to implement safety measures against all safety management information collected from clinical trials through to post-marketing, including adverse drug events and medical device failures.

My case evaluation duties involve gathering and evaluating the safety management information from around the world and reporting the results to the regulating authorities of each country, such as PMDA (Pharmaceuticals and Medical Devices Agency), FDA (United States Food and Drug Administration), and EMA (European Medicines Agency). I’m currently handling the case evaluations for domestic post-marketing products such as PADCEV (therapeutic agent for urothelial cancer) and Evrenzo (therapeutic agent for renal anemia). Patients’ information may not tally up correctly if we make errors in the evaluation and reporting process. Therefore, all safety management information must be accurately evaluated and reported without omission or error. We obviously have to avoid making any mistakes, but I’m finding it challenging to accomplish this day to day. Although there are many challenges, I find my work rewarding as I can feel that I’m contributing to patient safety.

I also perform various other duties related to projects besides case evaluation. One example is the project in which Astellas branches in Japan, Europe, and the U.S. are collaborating to implement digital transformation. This initiative aims to automate the entry of a staggering amount of safety management information into the database using digital technology to enable the speedy start of the evaluation work. Representatives from Japan, Europe, and the U.S. gathered to consider optimum procedures, but that didn’t necessarily mean that the Japanese procedures were suitable for the U.S. and Europe, and vice versa. As a result, I was required to discuss this issue with people in higher positions. Although it was very challenging to exchange views with people who had much more knowledge and experience than me, I achieved a great sense of accomplishment when we were ultimately able to figure out the best plan of action for Astellas. Members from each country considered what we could do for patients, and it was difficult to integrate everyone’s ideas to produce the best solution. But at the same time, we had a sense of fulfillment when we were able to understand each other’s perspectives and move our project forward.

While working every day, I am continuously considering how we can modify and improve the team’s tasks as well as my own. I also keep in mind that there is always the potential for development, and I constantly strive to gain insights for improvements.

Collaborating with other departments with patients in mind

One of Astellas’ values (Astellas Way) that we particularly emphasize is “Patient Focus.” Each of our employees in the Pharmacovigilance Department at Astellas has a sense of mission towards governing safety. I carry out my duties while constantly asking myself, “What would I do if someone important to me uses an Astellas’ product?” I strive to take sincere and proper action, even when it is difficult, to provide the value of safety to patients by proactively thinking about what should be done, not only for my own duties and products but also for other groups. For example, after an MR collects the safety management information, there may be instances where additional information is needed for evaluation, requiring us to ask the doctors or other reporters for further information. In such cases, we work closely with the doctors within our department and other groups to discuss what information is needed, sometimes across departments, to ensure safety measures can be developed.

Another appeal of Astellas is the corporate culture that welcomes employees to take up challenges. As I was very eager to improve my skills and knowledge quickly, I was able to get an opportunity to be in charge of a new product in my second year at Astellas. Launching a new product requires various considerations and adjustments. Although I faced a lot of difficulties, I believe I was able to build a foundation for myself by gaining this experience in my second year. I was really grateful that the team acknowledged my challenge and ensured I was always supported by experienced colleagues. I asked my senior colleagues a lot of questions at first as there were so many things I didn’t know, and I couldn’t make my own decisions. My colleague asked me, “What were your thoughts, and how did you decide that?” This question made me realize the importance of having my own standards of judgment when explaining my thoughts to others. I still treasure these words to this day.

Astellas has a culture where employees are encouraged to think and express their opinions proactively, regardless of age or job title. We have respectable and reliable staff members around the globe who inspire and support each other as we strive to grow together. We’re contributing to the world with the value of trust. For everyone who is looking to join the company, I’m looking forward to the day we can work together toward this goal.

Pharmacovigilance department introduction