Job Description

Our mission is to maximize value for patients by strengthening the trust in our medicines through the systematic collection and evaluation of safety information, ensuring that high-quality pharmaceuticals with proven efficacy and safety are delivered to those who need them. To fulfill this mission, we have established a globally harmonized framework that ensures compliance with country-specific pharmaceutical regulations, supported by an integrated pharmacovigilance (PV) system spanning the entire product lifecycle—from early development through commercial manufacturing. To promote the appropriate use of our products and deliver their full benefits to patients, we comprehensively manage all safety information—including adverse drug reactions and medical device malfunctions—from clinical development through the post-marketing phase.
In addition to meeting our regulatory reporting requirements, we work closely with health authorities to propose risk minimization measures and develop safety communication plans for healthcare professionals. For global products, these activities are conducted worldwide in close collaboration with regional PV colleagues. Furthermore, through the diligent management of post-marketing re-examination processes, we ensure that real-world safety data are appropriately reflected, thereby sustaining and enhancing the trust and confidence of our medicines.

Main Responsibilities of Pharmacovigilance

A Day in the Life of a Pharmacovigilance Professional (Example)

7:30: Wake up. Commute to the office by train (45 minutes).
8:45~9:30: Arrive at the office. Check the daily schedule and emails.
9:30~11:00: Evaluate the safety data trends collected over a certain period.
11:00~12:00: Team Meeting.
12:00~13:00: Lunch break. Often eat at the company cafeteria or go out.
13:00~14:00: Project meeting regarding a submission for approval.
14:00~15:30: Prepare periodic reports for submission to regulatory authorities.
15:30~16:30: Draft revisions for the Risk Management Plan.
16:30~17:30: Meeting with global team members.
17:30~17:45: Confirm the next day's schedule. Leave the office.

Message from Department Head

Pharmacovigilance (PV) is a critically important activity that ensures the safety of medicines and enables patients to receive treatment with confidence. By collecting and analyzing information related to adverse events and safety, and implementing necessary measures, we aim to minimize risks, promote appropriate use, and maximize the benefits of pharmaceutical products.

At Astellas, PV activities are conducted globally. Our headquarters in Japan, the U.S., and Europe work in close collaboration with local affiliates in the world to deliver safe medicines to patients around the world.

We continue to take on this important mission as one team, working closely with regulatory authorities—including Japan’s Ministry of Health, Labour and Welfare—to comply with strict regulatory requirements while providing high-value safety information that enables patients to use Astellas products with peace of mind.

What makes this work truly rewarding is the opportunity to contribute directly to people’s lives and health. Through early detection of adverse events and effective risk management, we help protect patients’ quality of life. This is a deeply meaningful mission that brings out the full value of our medicines.

PV roles are expected to have a global perspective and specialized expertise. By leveraging science and high-quality processes, we manage, analyze, and report safety information on a global scale—supporting the reliability of our products. Internally, we are also advancing innovative initiatives such as the use of AI and new systems, making PV a constantly evolving field.

PV is not just about safety management—it is about shaping the future of healthcare. If you are passionate about scientific progress and maximizing patient value, we invite you to take on this challenge with us.