Senior Manager, Global Patient Safety

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 have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.