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About the Role
The Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and post-marketing phases, including safety data aggregation, review, and analysis to support interpretation and benefit-risk assessment.
Responsibilities
- 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, and responses to health authority queries.
- Prepare and deliver presentations at Signal Management Team (SMT) meetings and participate in clinical study team meetings for assigned molecules compounds.
- Participate in other risk management activities as appropriate for assigned compounds.
- Represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC) and Independent Data Monitoring Committees (IDMC).
- Utilize experience in data manipulation and visualization (Excel, PIVOT tables, etc.) for safety analysis.
- Actively participate in process improvement initiatives, such as the development and maintenance of relevant SOPs, WIs, and supporting documents.
Requirements
- Master of science degree, PhD, or PharmD.
- Previous safety or relevant clinical experience in the pharmaceutical industry required, typically with at least 5+ years of risk management or relevant clinical experience in pharmaceutical/biotech industry or health authority.
- Clinical experience and/or industry experience in the TA of interest is a plus.
Skills
- Data manipulation
- Data visualization
- Excel
- PIVOT tables
Location
- On-site
Work Type
- Full-time
Experience Level
- 5+ years
Education Level
- Master of science degree
- PhD
- PharmD
Benefits
- 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
- Family support benefits
About the Company
- Regeneron is committed to building a workplace with an inclusive culture.
- Regeneron believes we do our best work when we are together.
Equal Opportunity
- 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.