Global Patient Safety Manager – Scientific Lead

BioSpace; Dublin (OH); On-site; USD 74,000 - 121,000; Full time

Job summary

Regeneron is seeking a Manager to join our Global Patient Safety Sciences team in Dublin. You will lead signal detection activities, evaluate safety signals, and manage safety documents (DSUR, PSUR, and RMP) for compounds in clinical development and post-marketing.

The role involves presenting at SMT meetings, collaborating with cross-functional teams including RSOC and IDMC, and contributing to safety data visualization and process improvements. Travel up to 25% may be required.

Qualifications

• Minimum Master degree, PharmD, PhD is required.
• At least 5+ years of risk management or relevant clinical experience in pharma/biotech or health authority.
• Experience in signal detection and safety surveillance.

Responsibilities

• Complete signal detection activities in line with safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Manage preparation and review of safety documents (DSUR, PSUR, RMP).
• Prepare and deliver presentations at SMT meetings; participate in clinical study team meetings for assigned compounds.
• Participate in risk management activities for assigned compounds; represent GPS on cross-functional teams (RSOC, IDMC).
• Demonstrate data manipulation/visualization (Excel, Pivot tables) for safety analysis.

Skills

Signal detection

Data analysis

Safety communications

Education

Master's degree

PharmD

PhD

Tools

Excel

Pivot tables

Job description

Regeneron is seeking a Manager to join our Global Patient Safety Sciences team in Dublin. You will lead signal detection activities, evaluate safety signals, and manage safety documents (DSUR, PSUR, and RMP) for compounds in clinical development and post-marketing.

The role involves presenting at SMT meetings, collaborating with cross-functional teams including RSOC and IDMC, and contributing to safety data visualization and process improvements. Travel up to 25% may be required.