Global Patient Safety Manager: Signals & Risk Lead

Regeneron Pharmaceuticals, Inc.; Dublin; In loco; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Regeneron Pharmaceuticals, Inc. is seeking a Manager to join the Global Patient Safety Sciences team in Dublin, Ireland.

The role focuses on safety strategies for molecules in clinical development and post-marketing, with responsibilities in signal detection, evaluation, and safety documentation. The position requires a Master’s degree or higher (PharmD/PhD), 5+ years in pharmacovigilance, and strong data manipulation skills.

Competenze

• Minimum Master degree, PharmD, PhD.
• 5+ years of risk management or relevant clinical experience in pharma/biotech industry or health authority.
• Experience in TA of interest is a plus.
• Ability to apply FDA, EU and ICH guidelines governing pharmacovigilance activities.

Mansioni

• Perform signal detection activities per safety surveillance plan.
• Evaluate identified signals and author safety evaluation reports.
• Prepare/review DSUR, PSUR, and RMP; respond to health authority queries.
• Present at Safety Management Team (SMT) meetings; engage in study team meetings.

Conoscenze

Signal detection

Safety evaluation

Data analysis

Regulatory guidelines

Formazione

Master's degree

PharmD

PhD

Strumenti

Safety database

Descrizione del lavoro

Regeneron Pharmaceuticals, Inc. is seeking a Manager to join the Global Patient Safety Sciences team in Dublin, Ireland.

The role focuses on safety strategies for molecules in clinical development and post-marketing, with responsibilities in signal detection, evaluation, and safety documentation. The position requires a Master’s degree or higher (PharmD/PhD), 5+ years in pharmacovigilance, and strong data manipulation skills.