Ophthalmology: Global Patient Safety Lead

Regeneron Pharmaceuticals, Inc.; Dublin; Ibrido; EUR 120.000 - 170.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonuses

Equity awards

Pension plan

401(k) company match

Health and wellness programs

Paid time off

Family support benefits

Descrizione del lavoro

Regeneron Pharmaceuticals, Inc. is looking for an Associate Director to lead Global Patient Safety activities for Ophthalmology. The role focuses on safety data aggregation, evaluation, and safety document preparation across clinical development and post‑marketing phases.

You will contribute to signal management, safety reporting, and cross-functional teamwork, with on-site presence in Dublin and travel as needed, shaping risk management strategies for Regeneron’s ophthalmology portfolio.

Competenze

• Master’s, PhD, or PharmD required or terminal degree preferred.
• 10+ years in risk management in pharma/biotech or health authority.
• 8–10+ years of risk management or clinical experience in pharma/biotech/health authority.

Mansioni

• Execute signal detection activities per the safety surveillance plan.
• Evaluate signals and author safety evaluation reports.
• Prepare/review safety documents (DSUR, PSUR, RMP) and respond to authorities.
• Present at SMT meetings and participate in study teams for assigned compounds.
• Contribute to risk management activities and SOP/WIs development.
• Represent GPS on cross-functional/regulatory committees as needed.

Conoscenze

Signal detection

Safety data review

Safety documentation

Verbal & written communication

Cross-functional collaboration

Formazione

Master’s, PhD or PharmD

Descrizione del lavoro

Regeneron Pharmaceuticals, Inc. is looking for an Associate Director to lead Global Patient Safety activities for Ophthalmology. The role focuses on safety data aggregation, evaluation, and safety document preparation across clinical development and post‑marketing phases.

You will contribute to signal management, safety reporting, and cross-functional teamwork, with on-site presence in Dublin and travel as needed, shaping risk management strategies for Regeneron’s ophthalmology portfolio.