Global Patient Safety Sciences Lead

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

Descrizione del lavoro

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director to lead Global Patient Safety Sciences in a hybrid setting. You will oversee signal management, safety surveillance, and benefit‑risk assessments across clinical development and post‑marketing programs.

You will collaborate with study teams, safety committees and external monitoring groups to ensure robust safety records and timely regulatory responses.

Competenze

• Master’s degree, PhD or PharmD.
• At least 10 years’ relevant pharmaceutical, biotechnology or health authority experience.
• Knowledge of FDA, EU and ICH pharmacovigilance requirements.
• Experience using safety databases for medical case review and simple queries.
• Clear safety communication, prioritisation, self-discipline and proactive delivery.
• Therapeutic-area clinical or industry experience is advantageous.
• Board certification is preferred.

Mansioni

• Lead safety surveillance, signal evaluation and benefit‑risk assessments for clinical development and post‑marketing activities.
• Collaborate with clinical study teams and cross‑functional safety committees.
• Manage safety documents including DSURs, PSURs, RMPs and health authority responses.
• Present at Signal Management Team meetings and support assigned clinical study teams.
• Represent GPS on cross‑functional safety committees and external Independent Data Monitoring Committees.
• Strengthen safety processes by maintaining SOPs and working instructions.

Formazione

Master’s degree

PhD

PharmD

Descrizione del lavoro

Regeneron Pharmaceuticals, Inc. is seeking an Associate Director to lead Global Patient Safety Sciences in a hybrid setting. You will oversee signal management, safety surveillance, and benefit‑risk assessments across clinical development and post‑marketing programs.

You will collaborate with study teams, safety committees and external monitoring groups to ensure robust safety records and timely regulatory responses.