Temp Mgr Global Patient Safety Sciences

Regeneron Pharmaceuticals • Tarrytown, GA

5d • Onsite

About The Position

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. This includes safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment.

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

Nice To Haves

• Clinical experience and/or Industry experience in the TA of interest is a plus

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, 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 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), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron
• Experience in data manipulation and visualization (Excel, PIVOT tables, etc) for safety analysis
• Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager