Global Patient Safety Lead - On-site Dublin

Regeneron Pharmaceuticals, Inc.; Dublin; On-site; EUR 74,000 - 121,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Dublin seeks a Manager to join Global Patient Safety Sciences. You will drive safety data aggregation, signal management, and safety evaluations for molecules in clinical development and post‑marketing phases.

The role requires expertise in pharmacovigilance, preparation of DSUR/PSUR/RMP, and collaboration with cross‑functional teams to ensure rigorous safety interpretation and risk management. On‑site four days a week with possible travel.

Qualifications

• Minimum Master degree, PharmD, PhD
• Experience in 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
• Ability to apply FDA, EU and ICH guidelines governing pharmacovigilance activities for both clinical trial and post‑marketing environments
• Ability to work with a safety system database for medical case review and simple queries
• Demonstrates advanced understanding of safety surveillance activities and principles; operates under supervision by more senior GPS safety sciences team

Responsibilities

• Complete signal detection activities in line with approved safety surveillance plan
• Perform signal evaluation and author the safety evaluation reports
• Prepare and review safety documents including DSUR, PSUR, RMP, and responses to health authority queries
• Deliver presentations at SMT meetings and participate in clinical study teams for assigned compounds
• Represent GPS on cross‑functional teams (RSOC, IDMC) and other external teams
• Data manipulation and visualization for safety analysis (Excel, Pivot tables)
• Participate in process improvement and SOP/WI development

Skills

Safety data analysis

Data visualization

Communication skills

Cross-functional collaboration

Education

Master's degree

PharmD

PhD

Job description

Regeneron Pharmaceuticals, Inc. in Dublin seeks a Manager to join Global Patient Safety Sciences. You will drive safety data aggregation, signal management, and safety evaluations for molecules in clinical development and post‑marketing phases.

The role requires expertise in pharmacovigilance, preparation of DSUR/PSUR/RMP, and collaboration with cross‑functional teams to ensure rigorous safety interpretation and risk management. On‑site four days a week with possible travel.