Global Patient Safety Manager — Signals & Risk Oversight

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

Job summary

Regeneron Pharmaceuticals seeks a Manager to join the Global Patient Safety Sciences (GPS) team in Dublin. The role focuses on safety strategies for molecules in development and post-marketing, including data aggregation, review, and risk assessment to support benefit-risk decisions.

The role involves signal detection/evaluation, preparing safety documents (DSUR/PSUR/RMP), and presenting findings at SMT meetings, with collaboration across cross-functional teams.

Qualifications

• Minimum Master degree, PharmD, PhD.
• 5+ years of safety or relevant clinical experience in the pharmaceutical/biotech industry or with health authorities.
• Clinical or industry experience in the therapeutic area of interest is a plus.
• Ability to apply FDA, EU and ICH guidelines for pharmacovigilance in clinical trials and post-marketing environments.
• Ability to work with a safety system database for medical case review and queries.
• Demonstrates advanced understanding of safety surveillance and works under supervision of senior GPS team members.

Responsibilities

• Complete signal detection activities per the safety surveillance plan.
• Perform signal evaluation and author the safety evaluation reports.
• Prepare and review safety documents (DSUR, PSUR, RMP) and respond to health authority queries.
• 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) as needed.
• Work with safety databases for medical case review and queries.
• Contribute to SOPs, WIs and related documentation.

Skills

Safety surveillance

Data analysis

Regulatory knowledge

Clinical development

Communication

Education

Master degree

PharmD

PhD

Tools

Excel

Pivot tables

Job description

Regeneron Pharmaceuticals seeks a Manager to join the Global Patient Safety Sciences (GPS) team in Dublin. The role focuses on safety strategies for molecules in development and post-marketing, including data aggregation, review, and risk assessment to support benefit-risk decisions.

The role involves signal detection/evaluation, preparing safety documents (DSUR/PSUR/RMP), and presenting findings at SMT meetings, with collaboration across cross-functional teams.