Senior Manager, Global Patient Safety Sciences
Location: Tarrytown
Posted on: June 23, 2025
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Job Description:
The Senior Manager of Global Patient Safety (GPS) will play a
key scientific role in safety strategies for molecules in clinical
development and post-marketing phases in the assigned Therapeutic
Area. We will expect this to include safety data aggregation,
review and analysis to support appropriate safety interpretation
and benefit-risk assessment. In this role, a typical day might
include: Complete signal detection activities in line with approved
safety surveillance plan Perform signal evaluation for any
identified signals and author the safety evaluation reports Manage
preparation and review of safety documents including DSUR, PSUR,
RMP, response to health authority or other queries Prepare and
deliver presentations at Signal Management Team (SMT) meetings;
participate in clinical study team meetings for assigned compounds
Participate in other risk management activities as appropriate for
assigned compounds We may ask you to represent GPS on
cross-functional teams, including Regeneron Safety Oversight
Committee (RSOC), Independent Data Monitoring Committees (IDMC) and
other teams with members external to Regeneron Actively participate
in process improvement initiatives e.g. the development and
maintenance of relevant SOPs, WIs and supporting documents This
role might be for you if can/have: Ability to apply relevant FDA,
EU and ICH guidelines, initiatives and regulations governing
pharmacovigilance activities for both clinical trial and
post-marketing environments Ability to work with a safety system
database for purposes of medical case review and simple queries
Able to be proactive and self-disciplined, you can meet
deliverables, and effectively use your time and prioritize Ability
to effectively communicate (verbal and written) safety findings To
be considered for this opportunity, you must have the following:
Minimum a Master's, PhD, or PharmD 7 years of relevant risk
management experience in the pharmaceutical/ biotech industry or
health authority 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. Salary Range (annually) $148,300.00
- $241,900.00
Keywords: , East Brunswick , Senior Manager, Global Patient Safety Sciences, Science, Research & Development , Tarrytown, New Jersey