We are looking for an Associate Manager, Global Patient Safety with a good background in GVP operational experience. This role will provide an opportunity to ensure our systems matter by updating procedures with our Japanese partners and working on local SOPs. We are a small yet multifaceted organisation on the path of consistent expansion, where each team member’s contribution is invaluable. Join us in building an environment where your insights can contribute to our direction and impact in the industry.

A typical day may include:

Interacting with colleagues both internal and external to GPS on issues related to GVP/GPSP training, EPPV implementation, self-inspection, PMS operation, Safety system implementation and maintenance.

Managing the oversight of GVP and GPSP outsourced operations.

Contribute to development and maintenance of relevant SOPs and supporting documents.

Actively participate in process improvement activities within Regeneron Japan PV.

Working cross-functionally with groups external to GPS to obtain results for: J-GVP/GPSP essential documents such as GVP/GPSP organization structure, documents related to assessment and implementation of the safety assurance measures, EPPV, Self-inspection, training and education, GVP/GPSP system implementation document related to interactions with Sanyaku and MAH.

This role might be for you if:

You have a proven understanding of relevant PMDA/MHLW and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.

Contributes to and leads organizational projects and goals to support their timely completion.

Proficiency in supporting regulatory authority inspection such as PMDA Re-examination, MAH license renews and GCP Reliability Inspection.

Expertise in working on complex projects, such as function/team improvement projects, Safety Database implementation projects, Business license succession including safety data transfers.

To be considered for this opportunity, we require a Bachelor’s degree or equivalent experience (BS degree preferred), at least 3 years of relevant pharmacovigilance experience in the pharmaceutical or biotech industry.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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.