Global Patient Safety Associate Director - Strategy Lead

Regeneron Pharmaceuticals, Inc.; Dublin; Ibrido; EUR 120.000 - 180.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Equity awards

Pension plan

Health benefits

Paid time off

Descrizione del lavoro

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to join its Global Patient Safety (GPS) team in Dublin, Ireland.

The role focuses on safety strategies for molecules in clinical development and post‑marketing, including data aggregation, safety interpretation and benefit‑risk assessments. Located in Dublin with 3 days on site per week and ~25% travel, the position offers a chance to influence safety programs across development stages while collaborating with RSOC, IDMC and

Competenze

• Master's, PhD or PharmD (terminal degree)
• 10+ years of risk management experience in pharma/biotech or health authority
• Experience in safety or clinical safety in pharma/biotech industry
• Ability to apply FDA/EU/ICH pharmacovigilance guidelines

Mansioni

• Complete signal detection activities per safety surveillance plan
• Perform signal evaluation and author safety evaluation reports
• Prepare/review DSUR, PSUR, and RMP documents and respond to health authorities
• Prepare and present at SMT meetings; collaborate with clinical study teams
• Represent GPS on cross-functional teams (RSOC, IDMC) as needed
• Provide medical review for assigned compounds
• Contribute to SOPs, WIs and related documents for process improvement

Conoscenze

Signal detection

Pharmacovigilance

Risk management

Regulatory guidelines (FDA/EMA/ICH)

Safety reporting

Formazione

Master's, PhD or PharmD

Strumenti

Safety database

DSUR/PSUR/RMP

Descrizione del lavoro

Regeneron Pharmaceuticals, Inc. seeks an Associate Director to join its Global Patient Safety (GPS) team in Dublin, Ireland.

The role focuses on safety strategies for molecules in clinical development and post‑marketing, including data aggregation, safety interpretation and benefit‑risk assessments. Located in Dublin with 3 days on site per week and ~25% travel, the position offers a chance to influence safety programs across development stages while collaborating with RSOC, IDMC and