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!
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
