I would like to minimize the risk of pharmaceutical products and contribute to patients' happy lives, to become a PV specialist.

Pharmacovigilance worker

2019 — Entered the Company after completing studies in pharmaceutical sciences

Protecting the “normal” lives of patients — this is the mission of PV in my opinion.

Protecting the “normal” lives of patients — this is the mission of pharmacovigilance (PV) if I were to express it in an easy-to-understand way. To make the best drug possible, it is important to strike a balance between its benefits (efficacy) and risks (safety). By minimizing adverse reactions and other risks while maximizing benefits, we enhance the value of pharmaceutical products and enable patients to undergo treatment with peace of mind. We at the Global Pharmacovigilance Department of Mitsubishi Tanabe Pharma collect relevant information concerning product safety from all parts of the world to conduct scientific analysis and evaluation, thereby promoting various activities to maintain safety from the development stage through the post-marketing stage.

After joining the Company, my first responsibility was PV work during the clinical trial stage. I was engaged in the establishment of an internal safety management structure in the clinical study planning stage, confirmation of safety data during an ongoing study, and examination of accumulated data following the study, among other activities. To guarantee the safety of subjects participating in clinical studies, we collect information concerning adverse events, etc. to analyze and evaluate safety. The results are incorporated into post-marketing research, information provision, and other measures when necessary. I accumulated experience for about two and a half years and engaged in various development projects, from the early development stage to the pre-application stage and in different disease areas.

I was assigned to a different group in the third year. Currently, I also handle post-marketing PV, in addition to PV in the development stage. I collect safety information related to products, including reports from physicians, literature, and academic presentations, based on which I prepare materials for revising package inserts; formulate investigation plans; and submit reports to the regulatory authority.

I pursued PV with an interest in healthy life expectancy based on my childhood experience.

During job hunting as a student, I mostly focused on PV positions at pharmaceutical companies. I selected Mitsubishi Tanabe Pharma among the companies I applied to because it appeared to be the one most keenly pursuing extension of healthy life expectancy. Whereas it is certainly a critical role of drugs to treat diseases, it is also important to help people live long, healthy lives. I wanted to do a job related to health longevity at a pharmaceutical company. I experienced a serious illness when I was young, and even after that I was sometimes bothered by the side effects of medication. From this experience, I decided that I wanted to engage in work that would reduce side effects as much as possible, develop better medicines, and help patients live happy lives. That's the reason I chose to work in PV.

Also, to be honest, one of the reasons I chose to work in the pharmaceutical industry is that the welfare system is well-organized and the pay is good. I believe that we need to be able to work happily for many years in order to contribute to people's happy lives.

Gaining diverse experience in a privileged environment to become a PV specialist.

In this way, I can concentrate on my PV work happily and with a sense of purpose. This is what I feel is the appeal of Mitsubishi Tanabe Pharma. Everyone around me, including my seniors and superiors, are friendly and easy to talk to, and I feel like it's a very comfortable workplace to work in. It provides systems and an environment for diverse workstyles. The Global PV Department has also proactively introduced teleworking. Because the workplace has an atmosphere where we can readily take paid holidays, we can devote ourselves both to work and to private life with a good balance.

There is a system for pharmaceutical products to be reexamined for efficacy and safety after a certain period of time after approval. At present, I am engaged in the preparation of a report on the reexamination of a product in the diabetes area. This is an important task in post-marketing PV. The safety information accumulated after approval is analyzed and evaluated afresh to formulate a persuasive statement.

I believe that the opportunity to be involved in a variety of tasks from the development stage to post-marketing is another feature of Mitsubishi Tanabe Pharma's PV program. Recently, initiatives using medical information databases have started in the PV area. I am also interested in this field and hope to undertake epidemiological research using a medical database. I have learned the basics at external seminars and from literature, and an accumulating practical experience by participating in an internal epidemiology project team. To become a specialist in PV, I would like to continue accumulating diverse experience and knowledge so that I can contribute to the safe and happy lives of patients.

Career step: 2019 Assigned to the Tokyo Head Office. Responsible for PV work at the development stage.
2021 Transferred to the Head Office (Osaka). Involved in post-marketing PV work, in addition to PV in the development stage.

* The affiliation and description in the article are those at the time of interview.