Global Patient Safety Lead – Senior Manager

BioSpace; Dublin (OH); On-site; USD 87,000 - 141,000; Full time

Job summary

Regeneron, a leader in science and medicine, is seeking a Senior Manager in Global Patient Safety in Dublin. You will drive safety strategies for molecules in clinical development and post-marketing, with focus on signal detection, evaluation, and safety reporting.

The role requires advanced degrees and extensive pharmacovigilance experience, with responsibility for DSUR/PSUR/RMP and cross-functional collaboration, onsite three days per week in Dublin.

Qualifications

• Master's, PhD, or PharmD required.
• Experience in pharmacovigilance within pharma/biotech or health authority.
• Ability to apply FDA, EU and ICH safety guidelines.

Responsibilities

• Complete signal detection activities per safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Prepare and review DSUR, PSUR, and RMP documents.
• Deliver presentations at SMT meetings and participate in study teams.
• Engage in risk management activities for assigned compounds.
• Represent GPS on cross-functional/regulatory committees.
• Contribute to SOPs, WIs and related documents.

Skills

Signal detection

Safety evaluation

Pharmacovigilance

Clinical safety data

Education

Master's, PhD or PharmD

Tools

Safety database

Job description

Regeneron, a leader in science and medicine, is seeking a Senior Manager in Global Patient Safety in Dublin. You will drive safety strategies for molecules in clinical development and post-marketing, with focus on signal detection, evaluation, and safety reporting.

The role requires advanced degrees and extensive pharmacovigilance experience, with responsibility for DSUR/PSUR/RMP and cross-functional collaboration, onsite three days per week in Dublin.