Global Patient Safety Senior Manager — Strategic Impact

BioSpace; Dublin (OH); Hybrid; USD 98.000 - 159.000; Vollzeit

Benefits dieser Stelle

Annual bonuses

Equity awards

Pension/retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance (medical, dental, vision, +1

Paid time off

Family support benefits

Zusammenfassung

Regeneron is seeking a Senior Manager in Global Patient Safety (GPS) to lead safety strategies for molecules in clinical development and post-marketing phases. The role focuses on safety data aggregation, review and analysis to support safety interpretation and benefit-risk assessment.

The position involves on-site work in Dublin with cross-functional collaboration on SMT and RSOC/IDMC, plus development of SOPs and process improvements in pharmacovigilance.

Qualifikationen

• Master's, PhD, or PharmD required.
• 7+ years of risk management experience in pharma/biotech or health authority.
• Ability to apply FDA, EU and ICH pharmacovigilance guidelines.
• Experience with safety system databases and medical case review.
• Strong communication of safety findings (verbal and written).

Aufgaben

• Complete signal detection activities per safety surveillance plan.
• Perform signal evaluation and author the safety evaluation reports.
• Prepare/review DSUR, PSUR, and RMP, and responses 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) and external groups.
• Contribute to process improvements and SOP/WI documentation.

Kenntnisse

Signal detection

Signal evaluation

Pharmacovigilance

Medical writing

Ausbildung

Master's/PhD/PharmD

Tools

Safety database

Jobbeschreibung

Regeneron is seeking a Senior Manager in Global Patient Safety (GPS) to lead safety strategies for molecules in clinical development and post-marketing phases. The role focuses on safety data aggregation, review and analysis to support safety interpretation and benefit-risk assessment.

The position involves on-site work in Dublin with cross-functional collaboration on SMT and RSOC/IDMC, plus development of SOPs and process improvements in pharmacovigilance.