Global Patient Safety Manager - Signals & Risk Analysis

Regeneron Pharmaceuticals; Tarrytown (GA); On-site; USD 150,000 - 190,000; Full time

Job summary

Regeneron Pharmaceuticals is seeking a Manager of Global Patient Safety to lead scientific safety strategies for molecules in development and post-marketing stages. Responsibilities include signal detection, evaluation, and preparation of DSUR/PSUR/RMP, plus presenting at SMT meetings and collaborating with cross-functional teams.

Candidates should have 5+ years in pharmaceutical safety or related clinical experience, with MS/PhD/PharmD and strong data analysis skills.

Qualifications

• Experience in signal detection activities.
• Experience in safety data aggregation, review and analysis.
• Strong data manipulation and visualization skills (Excel, Pivot tables).
• Prior work in pharma safety or risk management is required.

Responsibilities

• Complete signal detection activities in line with the safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Manage preparation and review of DSUR, PSUR, RMP, and safety responses.
• Deliver presentations at SMT meetings and participate in study team meetings.
• Participate in risk management activities for assigned compounds.
• Represent GPS on cross-functional teams (RSOC, IDMC) as needed.
• Actively participate in process improvement initiatives and SOP development.

Skills

Signal detection

Safety analysis

Data visualization

Pivot tables

Education

MS/PhD/PharmD

Tools

Excel

Job description

Regeneron Pharmaceuticals is seeking a Manager of Global Patient Safety to lead scientific safety strategies for molecules in development and post-marketing stages. Responsibilities include signal detection, evaluation, and preparation of DSUR/PSUR/RMP, plus presenting at SMT meetings and collaborating with cross-functional teams.

Candidates should have 5+ years in pharmaceutical safety or related clinical experience, with MS/PhD/PharmD and strong data analysis skills.