Global Patient Safety Senior Manager - Strategy Lead

Regeneron Ireland; Dublin; Hybrid; EUR 87,000 - 141,000; Full time

Job summary

Regeneron Ireland is seeking a Senior Manager to lead Global Patient Safety activities in Dublin with a strong emphasis on signal detection, evaluation, and safety documentation across clinical development and post‑marketing stages.

The role requires a Masters/PhD/PharmD with 7+ years of pharmacovigilance experience and proven ability to work with safety systems and regulatory guidelines. On‑site presence in Dublin three days per week is expected.

Qualifications

• Master's, PhD or PharmD required.
• 7+ years of risk management experience in pharma/biotech or health authority.
• Knowledge of FDA, EU and ICH pharmacovigilance guidelines and regulations.
• Experience with a safety system database for case review and queries.
• Strong verbal and written communication of safety findings.

Responsibilities

• Complete signal detection activities per safety surveillance plan.
• Perform signal evaluation and author safety evaluation reports.
• Manage preparation/review of DSUR, PSUR, RMP and health authority responses.
• Deliver presentations at SMT meetings and participate in clinical study teams.
• Participate in risk management activities for assigned compounds.

Skills

Verbal communication

Written communication

Time management

Prioritization

Education

Master's/PhD/PharmD

Job description

Regeneron Ireland is seeking a Senior Manager to lead Global Patient Safety activities in Dublin with a strong emphasis on signal detection, evaluation, and safety documentation across clinical development and post‑marketing stages.

The role requires a Masters/PhD/PharmD with 7+ years of pharmacovigilance experience and proven ability to work with safety systems and regulatory guidelines. On‑site presence in Dublin three days per week is expected.