仕事内容
Join Us in Ensuring Patient Safety Globally!
At our company, we are committed to safeguarding patient health worldwide through innovative pharmacovigilance practices. We are seeking a Senior Manager, Global Pharmacovigilance (GVP) to be based in Japan. Reporting directly to the Safety Management Officer, you will play a pivotal role in overseeing critical pharmacovigilance activities, including individual case safety reports (ICSRs), research reports (RRs), foreign safety measures (FSMTs), and aggregate reporting. If you thrive in a collaborative environment and are passionate about advancing global patient safety, this is your opportunity to make a meaningful impact.
A Typical Day:
Oversee and evaluate Japan ICSR, RR, and FSMT reports for accuracy and compliance.
Manage vendor activities related to pharmacovigilance, ensuring adherence to contracts and performance standards.
Author and update working instructions while conducting related training sessions.
Contribute to the development and implementation of Japan Risk Management Plans (J-RMPs) and ensure compliance with the associated activities.
Collaborate with cross-functional teams, including Medical Affairs, Regulatory Affairs, and external partners, to deliver key pharmacovigilance deliverables.
Support the preparation of safety sections for Japan New Drug Applications (J-NDAs) and address inquiries from the Pharmaceuticals and Medical Devices Agency (PMDA).
Lead process improvement initiatives to enhance quality and compliance in pharmacovigilance operations.
This Role May Be For You If:
You have over seven years of experience in pharmacovigilance or drug safety within the pharmaceutical or biotech industry.
You are well-versed in PMDA/MHLW and ICH guidelines and regulations governing pharmacovigilance activities.
You excel at managing complex projects, such as safety database implementations or license succession involving data migration.
You thrive in cross-functional collaborations and have experience working with teams like Medical Affairs and Regulatory Affairs.
You have successfully supported or led regulatory inspections, including PMDA Re-examinations and GCP Reliability Inspections.
You possess strong analytical and organizational skills, enabling you to oversee multiple projects simultaneously.
To Be Considered:
Candidates must have a Bachelor's degree or higher and at least seven years of experience in pharmacovigilance and post-marketing surveillance operations. Familiarity with contracting and managing external service providers is essential, along with prior global pharmacovigilance experience. Preferred candidates will have demonstrated success in regulatory authority inspections and cross-functional collaborations.
Why Join Us?
This is more than just a job—it’s an opportunity to contribute to a mission that directly impacts global patient safety. We offer a collaborative environment where innovation is encouraged, and your expertise will be valued and recognized.
Take the next step in your career and apply to join our dedicated team today!
本ポジションにご興味をお持ちいただけましたでしょうか。みなさまのご応募を心よりお待ち申し上げております。我々の企業理念であるRegeneron Wayを共に歩む、その第一歩を踏み出しましょう。当社では、多様性を大切にする企業文化に基づき、幅広い内容の福利厚生をご用意しております（内容は地域によって異なります）。米国の場合、ヘルス＆ウェルネスプログラム（医療保険、歯科治療や眼科治療に関する保険、生命保険および身体障がいに関する保険など）、フィットネスセンター、確定拠出年金（401k）、家族支援制度、株式報酬、年次ボーナス、有給休暇、および特別有給休暇制度（例：育児休暇、軍務休職）などがあり、対象となる社員の方であれば、すべての職位においてご利用いただけます。当社の、米国における福利厚生の詳細に関しましては、https://careers.regeneron.com/en/working-at-regeneron/total-rewards/をご参照ください。その他の国における福利厚生に関しましては、採用担当者までお問い合わせください。
最高の仕事を通じて最もすばらしい成功を手にするためには、社員が一丸となって働くことこそ重要である、という信念に則り、当社では多くの職種において、オフィス勤務を必須とさせていただいております。オフィス勤務に関する当社のポリシー、および勤務内容や勤務地に関するみなさまお一人おひとりの個別の条件につきましては、採用担当者にお問い合わせください。