Global Patient Safety - Senior Manager & Signals Lead

Regeneron Pharmaceuticals, Inc.; Dublin; On-site; EUR 87,000 - 141,000; Full time

Job summary

Regeneron is seeking a Senior Manager in Dublin to lead Global Patient Safety activities for molecules in clinical development and post-marketing. You will manage signal detection/evaluation, safety documentation, and risk management while collaborating with RSOC/IDMC teams.

The role requires a Master’s/PhD/PharmD and 7+ years of risk management experience, with strong communication skills and a focus on timely safety insights. On-site work 3 days per week in Dublin, Ireland.

Qualifications

• Master's, PhD or PharmD required.
• 7+ years of risk management experience in pharma/biotech or health authority.
• Knowledge of FDA, EU and ICH pharmacovigilance guidelines.
• Ability to work with safety systems for medical case review and queries.
• Proactive, self-disciplined, able to meet deliverables and priorities.
• Strong verbal and written communication of safety findings.

Responsibilities

• Perform signal detection and evaluations per safety surveillance plan.
• Author safety evaluation reports for identified signals.
• Prepare/review DSUR, PSUR, RMP and responses to health-authority queries.
• Deliver SMT presentations and participate in cross-functional study teams.
• Contribute to risk management activities for assigned compounds.

Skills

Signal detection

Signal evaluation

Safety documentation

Presentation skills

Risk management

Cross-functional collaboration

Education

Master's, PhD, or PharmD

Tools

Safety databases

Job description

Regeneron is seeking a Senior Manager in Dublin to lead Global Patient Safety activities for molecules in clinical development and post-marketing. You will manage signal detection/evaluation, safety documentation, and risk management while collaborating with RSOC/IDMC teams.

The role requires a Master’s/PhD/PharmD and 7+ years of risk management experience, with strong communication skills and a focus on timely safety insights. On-site work 3 days per week in Dublin, Ireland.