Overview
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 expect this to include safety data aggregation, review, and analysis to support appropriate safety interpretation and benefit-risk assessment.
Typical day might include
Complete signal detection activities in line with approved safety surveillance plan.
Perform signal evaluation for any identified signals and author safety evaluation reports.
Manage preparation and review of safety documents including DSUR, PSUR, RMP, and responses 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.
Represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC), and other teams with external members.
Actively participate in process improvement initiatives such as the development and maintenance of relevant SOPs, WIs, and supporting documents.
This role might be for you if you have the following
Ability to apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments.
Experience working with a safety system database for medical case review and simple queries.
Proactive and self-disciplined with the ability to meet deliverables, manage time, and prioritize effectively.
Effective communication (verbal and written) of safety findings.
Required qualifications
Minimum a Master's, PhD, or PharmD.
7+ years of relevant risk management experience in the pharmaceutical/biotech industry or a health authority.
Benefits and culture
Regeneron offers an inclusive culture with comprehensive benefits that vary by location.
In the U.S., benefits may include health and wellness programs (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 U.S., please visit our benefits page.
For other countries' specific benefits, please speak to your recruiter.
Equal Opportunity Employer
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.
Salary Range (annually)
$150,****** - $245,******
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