Global Patient Safety Lead — Scientific Strategy

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

Benefits offered by this job

Annual bonus

Equity awards

Pension benefits

401(k) company match

Health & wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support

Job summary

Regeneron Ireland is seeking a Manager to join the Global Patient Safety Sciences team in Dublin. The role will lead safety data aggregation, signal management, and the preparation of DSUR/PSUR/RMP documents, with on-site work four days a week and up to 25% travel.

You will collaborate with cross-functional teams, deliver safety presentations, and contribute to process improvements while applying FDA, EU and ICH pharmacovigilance guidelines.

Qualifications

• Minimum Master degree, PharmD, PhD
• Previous 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 relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments
• Ability to work with a safety system database for purposes of medical case review and simple queries
• Demonstrates advanced understanding of safety surveillance activities and principles; continues to operate under supervision by more senior members of the GPS safety sciences team
• Able to be proactive and self-disciplined, you can meet deliverables, and effectively use your time and prioritize
• Ability to effectively communicate (verbal and written) safety findings

Responsibilities

• Complete signal detection activities in line with approved safety surveillance plan
• Perform signal evaluation for any identified signals and author the safety evaluation reports
• Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other queries
• Prepare and deliver presentations at Signal Management Team (SMT) meetings; participate in clinical study team meetings for assigned compounds
• Participate in other risk management activities as appropriate for assigned compounds
• We may ask you to represent GPS on cross-functional teams, including Regeneron Safety Oversight Committee (RSOC), Independent Data Monitoring Committees (IDMC) and other teams with members external to Regeneron
• Experience in data manipulation and visualization (Excel, PIVOT tables, etc) for safety analysis
• Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents

Skills

Signal detection

Signal evaluation

Safety documentation

Safety risk management

Cross-functional collaboration

Data manipulation & visualization

Excel & Pivot tables

Process improvement

Presentation skills

Education

Master degree, PharmD, or PhD

Job description

Regeneron Ireland is seeking a Manager to join the Global Patient Safety Sciences team in Dublin. The role will lead safety data aggregation, signal management, and the preparation of DSUR/PSUR/RMP documents, with on-site work four days a week and up to 25% travel.

You will collaborate with cross-functional teams, deliver safety presentations, and contribute to process improvements while applying FDA, EU and ICH pharmacovigilance guidelines.