Career Recruitment Site

Correctly delivering information
on how to use medicine safely to
medical professionals

Pharmacovigilance Medical Safety Sayaka Nakajima

Aspiring for a pharmacovigilance position for communicating efficacy and risks

Since my father taught at a Faculty of Pharmacy, I had a vague idea from around high school that I wanted to be involved in a career related to medicine in the future.

I first became interested in a pharmacovigilance position when I was a senior in college, when I learned of its existence from a senior's job search.At that time, I also experienced side effects from over-the-counter drugs and realized the meaning of the phrase "drugs are risky." This experience reminded me of the need to properly provide information on safety as well as efficacy to healthcare professionals and patients.

When considering my career, I narrowed my focus to a pharmacovigilance position and made comparisons based on whether I could contribute to a greater number of patients. Astellas handles drugs for rare diseases and cancer diseases, where pharmacovigilance is an important part of the company, and is also involved in new drug development. Another reason I decided to join the company was the warm atmosphere I felt at roundtable discussions with senior managers and during interviews. This impression remained unchanged after I actually joined Astellas.

Ownership is important to deliver accurate safety information

For about five years since I joined the company, I have been working in the Pharmacovigilance Department in a group that formulates safety measures for products. Based on the results of the evaluation of safety information gathered and the preparation of periodic reports, we consider safety assurance measures such as revision of the package inserts as necessary, taking into account the balance of benefit-risk and other factors.

Astellas has products in a variety of therapeutic areas and phases, and the Pharmacovigilance Department is involved in both investigational and commercial products. Among them, I am in charge of oncology products. Investigational products are in various phases, from Phase I to the approval application stage, and marketed products include relatively young products before reexamination and mature products after reexamination, each of which requires different tasks. Currently, an investigational product that I have been in charge of for three years is in the process of filing for approval.
Although it requires strategy and accuracy within a tight timeline, it is a very valuable opportunity for me as a member of the Pharmacovigilance team, and I find it very rewarding.

One of the most memorable experiences in my work to date has been negotiating with an overseas team. When we applied for a Japan-specific survey on safety measures for a certain cancer product, we were unable to obtain the agreement of our European and American counterparts due to our intention "to take a consistent position in the world as a company.” Therefore, we gathered enough information to convince our overseas team members, and with the cooperation of many people across divisions, we eventually obtained agreement from the overseas team members, leading to the implementation of Japan's own safety measures. Although some problems occur because we are a global organization, I learned the importance of responding with strategies and policies as the contact charge in Japan, and of not only accepting but also proactively making proposals.

Growing in a culture that requires ideas and innovation

Among the five guiding principles (Astellas Way) that Astellas values, I experienced 'Openness' and 'Ownership' when I participated in the One Asia M&D Forum, an in-house event held every year by volunteers, as a secretariat member. The forum is like an in-house academic conference with a single theme and targets a wide range of departments, including development, regulatory affairs, medical affairs, and pharmacovigilance, and also serves to train newcomers. We had many discussions with members from other Asian regions from the preparatory stage. It was difficult to organize opinions from different departments and regions in parallel with my regular work, but it was a great experience for me to broaden my internal connections with members with whom I would not normally have contact.

I am also conscious of 'Integrity' on a daily basis. I receive many requests on a daily basis to review not only the products I am in charge of, but also the improvements and procedures common to all products, and I try to take the initiative in responding politely, even if they are addressed to the entire group.Although they may seem trivial, I feel that in the big picture, they lead to improvements in the quality of the deliverables and procedures themselves and contribute to the product project, the group, and the department.

Astellas has a mentor-mentee system, which allows you to work closely with a senior staff member in charge of your work for the first year and a half after you join the company, as well as a full range of in-house training and career programs. There are numerous opportunities to improve my skills, and I feel that this is an environment where I can work spontaneously with a spirit of exploration. I have been in the same department for five years, and I have yet to run out of interest in the business. I would like to actively take on tasks such as reexamination of applications and document revision, which I have never worked on before.

Pharmacovigilance introduction