Global Patient Safety Lead: Signals & Strategy

Regeneron UK Limited; Uxbridge; On-site; GBP 90,000 - 130,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Pension plan

401(k) company match

Health and wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support benefits

Job summary

Regeneron UK Limited seeks a Senior Manager for Global Patient Safety (GPS) to lead safety strategies for molecules in development and post-marketing. You will drive signal detection, evaluation and safety documentation, while collaborating with cross-functional teams across Regeneron.

Requires 7+ years in pharmacovigilance or risk management, plus a Master's, PhD or PharmD. Role based in Uxbridge, with 3 days on site per week.

Qualifications

• Master's, PhD or PharmD required.
• 7+ years of risk management experience in pharma/biotech or health authority.
• Ability to apply FDA/EU/ICH pharmacovigilance guidelines in clinical and post-marketing settings.
• Experience managing safety documents (DSUR, PSUR, RMP) and safety reports.

Responsibilities

• Complete signal detection in line with the safety surveillance plan.
• Evaluate signals and author safety evaluation reports.
• Prepare and review DSUR, PSUR, RMP and regulatory queries.
• Deliver presentations at SMT meetings and participate in study teams.
• Lead risk management activities and drive process improvements.
• Represent GPS on cross-functional teams and safety oversight committees.

Skills

Signal detection

Safety data analysis

Regulatory knowledge

Medical writing

Cross-functional collaboration

Public speaking

Education

Master's degree

PhD

PharmD

Tools

Safety database

Job description

Regeneron UK Limited seeks a Senior Manager for Global Patient Safety (GPS) to lead safety strategies for molecules in development and post-marketing. You will drive signal detection, evaluation and safety documentation, while collaborating with cross-functional teams across Regeneron.

Requires 7+ years in pharmacovigilance or risk management, plus a Master's, PhD or PharmD. Role based in Uxbridge, with 3 days on site per week.