Global Patient Safety Senior Manager — Signals & Strategy

BioSpace; Kuah; Hybrid; MYR 354,000 - 577,000; Full time

Benefits offered by this job

Regulatory time-off policies

Job summary

Regeneron is seeking a Senior Manager to join our Global Patient Safety team. The role focuses on safety data aggregation and evaluation to support benefit-risk assessment across clinical development and post-marketing stages.

Location is Dublin, with 3 days per week on site. The position offers an opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide and to participate in cross-functional safety activities with RSOC/IDMC

Qualifications

• Master's, PhD, or PharmD required.
• 7+ years of risk management experience in pharma/biotech or health authority.
• Ability to apply FDA, EU and ICH guidelines for pharmacovigilance in both clinical trials and post-marketing.
• Experience with safety system databases for medical case review.

Responsibilities

• Complete signal detection activities in line with safety surveillance plan.
• Perform signal evaluation and author the safety evaluation reports.
• Prepare and review safety documents including DSUR, PSUR, RMP; respond to health authority queries.
• Prepare and deliver SMT presentations; participate in clinical study team meetings for assigned compounds.
• Participate in other risk management activities for assigned compounds.
• Represent GPS on cross-functional teams including RSOC, IDMC and other external members.
• Contribute to process improvements and maintenance of SOPs/WIs.

Skills

Master's/PhD/PharmD

7+ years experience

FDA/EU/ICH guidelines

Safety database

Proactive discipline

Safety communication

Education

Master's degree

PhD

PharmD

Job description

Regeneron is seeking a Senior Manager to join our Global Patient Safety team. The role focuses on safety data aggregation and evaluation to support benefit-risk assessment across clinical development and post-marketing stages.

Location is Dublin, with 3 days per week on site. The position offers an opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide and to participate in cross-functional safety activities with RSOC/IDMC