Global Patient Safety Manager - Lead Safety Strategy & Analytics

Regeneron Pharmaceuticals, Inc.; Dublin; Presencial; EUR 120.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental and vision insurance

Paid time off & holidays

Wellness programs

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Global Patient Safety Scientist to lead safety strategies for compounds in clinical development and post-marketing phases.

The role emphasizes signal detection, safety evaluations, and preparation of safety documents with collaboration across RSOC, IDMC, and SMT. The candidate will analyze safety data, prepare reports, and contribute to ongoing process improvements while representing GPS in cross-functional teams and ensuring compliance with

Formación

• 5+ years of regulatory safety or relevant clinical experience in pharma/biotech
• Experience with DSUR, PSUR, and risk management plans
• Ability to apply FDA, EU and ICH guidelines
• Experience with safety system databases and medical case review
• Strong communication and presentation skills

Responsabilidades

• Perform signal detection activities per safety surveillance plan
• Prepare and review safety documents including DSUR, PSUR, and RMP
• Prepare and deliver presentations at SMT meetings; participate in study teams
• Represent GPS on cross-functional teams (RSOC, IDMC)
• Engage in data manipulation/visualization for safety analyses
• Contribute to SOP/WIs and process improvements

Conocimientos

Signal detection

Pharmacovigilance

Safety surveillance

Data analysis

Presentation skills

Cross-functional collaboration

Regulatory guidelines (FDA/EU/ICH)

Herramientas

Excel

Pivot tables

Descripción del empleo

Regeneron Pharmaceuticals, Inc. is seeking a Manager, Global Patient Safety Scientist to lead safety strategies for compounds in clinical development and post-marketing phases.

The role emphasizes signal detection, safety evaluations, and preparation of safety documents with collaboration across RSOC, IDMC, and SMT. The candidate will analyze safety data, prepare reports, and contribute to ongoing process improvements while representing GPS in cross-functional teams and ensuring compliance with