At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager, Pharmacovigilance Safety Operations Japan to join our Global Patient Safety team, supporting our Japan business in a hybrid work mode. In this role, you will oversee Japan pharmacovigilance reporting and compliance activities while collaborating with cross-functional teams, external partners, and service providers. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
Japan
Work model: Hybrid
- Serve as the primary contact for Japan ICSR, research report, and FSMT activities.
-
Review vendor-prepared safety evaluations and PMDA submissions for accuracy.
-
Oversee pharmacovigilance service providers and monitor contract compliance.
-
Drive process improvements that strengthen quality and compliance.
-
Author and update working instructions and deliver related training.
-
Contribute to J-RMP development and execution activities.
-
Partner with external departments and license partners on safety deliverables.
-
You build collaborative relationships to support effective safety outcomes.
- More than 7 years of pharmacovigilance and post-marketing surveillance operations experience.
-
Strong knowledge of PMDA, MHLW, and International Council for Harmonisation guidelines and regulations.
-
Experience supporting Japan aggregate reporting and local pharmacovigilance activities.
-
Experience managing external service providers and vendor relationships.
-
Experience supporting J-NDA safety content and responding to PMDA inquiries.
-
Experience with regulatory inspections, including PMDA re-examination, MAH license renewal, or GCP reliability inspection.
-
Experience leading complex projects, including team improvement, safety database implementation, or safety data migration initiatives.
-
Experience collaborating with Medical Affairs, Regulatory Affairs, Sales and Marketing, and Clinical Development teams.
-
Prior global pharmacovigilance experience.
-
Strong project management and cross-functional collaboration skills.
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.
