Manager Global Patient Safety (Cardiovascular & Metabolism)
Company: Regeneron Pharmaceuticals, Inc.
Location: Basking Ridge
Posted on: January 25, 2023
Job Description:
The Manager of Global Patient Safety (GPS) will play a key
scientific role in safety strategies for cardiovascular and
metabolism (CVM) molecules in clinical development and
post-marketing phases. We will expect this to include safety data
aggregation, review and analysis to support appropriate safety
interpretation and benefit-risk assessment.
- Complete signal detection activities in line with approved
safety surveillance plan for assigned molecules in cardiovascular
and metabolism (CVM) molecules
- 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: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 apply GPS safety system
database for purposes of medical case review and simple queries.
Ability to optimally communicate (verbal and written) safety
findings. Previous safety or relevant clinical experience in the
pharmaceutical industry required, typically with at least 5 years
of risk management experience.Does this sound like you? Apply now
to take your first steps toward living the Regeneron Way! We have
an inclusive and diverse culture that provides amazing benefits
including health and wellness programs, fitness centers and stock
for 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. We will ensure
that individuals with disabilities are provided reasonable
accommodations to participate in the job application process.
Please contact us to discuss any accommodations you think you may
need.Does this sound like you? Apply now to take your first steps
toward living the Regeneron Way! We have an inclusive and diverse
culture that provides comprehensive benefits including health and
wellness programs, fitness centers and 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. We will ensure that
individuals with disabilities are provided reasonable
accommodations to participate in the job application process.
Please contact us to discuss any accommodations you think you may
need.The salary ranges provided are shown in accordance with U.S.
law and apply to U.S. based positions, where the hired candidate
will be located in the U.S. If you are outside the U.S, please
speak with your recruiter about salaries and benefits in your
location.Salary Range (annually) $102,600.00 - $167,400.00
Keywords: Regeneron Pharmaceuticals, Inc., Newark , Manager Global Patient Safety (Cardiovascular & Metabolism), Executive , Basking Ridge, New Jersey
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