Global Patient Safety Leader – Senior Manager

Regeneron Pharmaceuticals, Inc; Dublin; On-site; EUR 87,000 - 141,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Dublin seeks a Senior Manager for Global Patient Safety to shape safety strategies for molecules in development and post-marketing. You will lead signal detection and evaluation, and prepare DSUR/PSUR/RMP while collaborating with cross-functional teams.

The role requires 7+ years in risk management in pharma/biotech, knowledge of FDA/EU/ICH guidelines, and strong written/verbal safety communication skills. Three days on site in Dublin are 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.
• Ability to communicate safety findings clearly (verbal and written).

Responsibilities

• Complete signal detection activities per safety surveillance plan.
• Perform signal evaluation and author the safety evaluation reports.
• Prepare and review DSUR, PSUR, and RMP; respond to health authority queries.
• Prepare and deliver SMT presentations; participate in clinical study teams.
• Participate in other risk management activities for assigned compounds.
• Represent GPS on cross-functional teams (RSOC, IDMC) as needed; improve SOPs and related documents.

Skills

Verbal communication

Written communication

Proactive

Time management

Education

Master's degree

PhD

PharmD

Tools

Safety database

Job description

Regeneron Pharmaceuticals, Inc. in Dublin seeks a Senior Manager for Global Patient Safety to shape safety strategies for molecules in development and post-marketing. You will lead signal detection and evaluation, and prepare DSUR/PSUR/RMP while collaborating with cross-functional teams.

The role requires 7+ years in risk management in pharma/biotech, knowledge of FDA/EU/ICH guidelines, and strong written/verbal safety communication skills. Three days on site in Dublin are expected.