Global Patient Safety Strategy Lead

Regeneron Ireland; Dublin; Sur place; EUR 104 000 - 169 000; Plein temps

Avantages offerts par ce poste

Annual bonuses

Equity awards

Pension or retirement benefits

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Résumé du poste

Regeneron Ireland seeks an Associate Director to join Global Patient Safety in Dublin, on-site three days per week with up to 25% travel. You will lead safety data aggregation, review and analysis to support safety interpretation and benefit-risk assessments for molecules in development and post-marketing.

The role demands a Master’s/PhD/PharmD with 10+ years in risk management within pharma/biotech, and strong knowledge of FDA/EU/ICH pharmacovigilance.

Qualifications

• Master's, PhD, or PharmD; terminal degree preferred.
• 10+ years of risk management experience in pharma/biotech or health authority.
• Strong knowledge of FDA, EU and ICH pharmacovigilance guidelines.
• Ability to work with safety databases and generate medical reviews.
• Proactive, self-disciplined, and able to meet deliverables.
• Excellent verbal and written safety communication.

Responsabilités

• Complete signal detection in line with safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Prepare/Review DSUR, PSUR, and RMP documents and regulator responses.
• Deliver presentations at SMT meetings.
• Participate in clinical study teams for assigned compounds.
• Contribute to risk management activities and SOP maintenance.
• Represent GPS on cross-functional/regulatory committees as needed.

Connaissances

Risk management

Clinical safety

Communication skills

Self-motivation

Formation

Master's degree

PhD

PharmD

Outils

Safety system databases

DSUR/PSUR/RMP writing

Description du poste

Regeneron Ireland seeks an Associate Director to join Global Patient Safety in Dublin, on-site three days per week with up to 25% travel. You will lead safety data aggregation, review and analysis to support safety interpretation and benefit-risk assessments for molecules in development and post-marketing.

The role demands a Master’s/PhD/PharmD with 10+ years in risk management within pharma/biotech, and strong knowledge of FDA/EU/ICH pharmacovigilance.