Global Patient Safety Lead — Signals & Risk

Regeneron UK Limited; Uxbridge; On-site; GBP 80,000 - 110,000; Full time

Job summary

Regeneron UK Limited is seeking a Manager to join the Global Patient Safety Sciences team in the Uxbridge area. The role focuses on safety strategies for molecules in clinical development and post-marketing phases, including signal detection, evaluation, and DSUR/PSUR/RMP preparation.

The position requires a Master’s degree or higher (PharmD/PhD preferred) with 5+ years in pharmacovigilance or related clinical experience, and strong communication skills for presentations and cross-functional

Qualifications

• Minimum Master degree, PharmD, PhD.
• 5+ years of risk management or relevant clinical experience in pharmaceutical/biotech industry or health authority.
• Clinical experience and/or Industry experience in the TA of interest is a plus.
• Ability to apply FDA, EU and ICH guidelines governing pharmacovigilance activities for both clinical trial and post-marketing environments.
• Ability to work with a safety system database for medical case review and queries.

Responsibilities

• Complete signal detection activities in line with approved safety surveillance plan.
• Perform signal evaluation and author the safety evaluation reports.
• Manage preparation and review of safety documents including DSUR, PSUR, RMP, responses to health authority or other queries.
• Prepare and deliver presentations at Signal Management Team (SMT) meetings.
• Participate in clinical study team meetings for assigned compounds.
• Participate in other risk management activities as appropriate for assigned compounds.

Skills

Signal detection

Safety surveillance

Presentation skills

Communication skills

Education

Master's degree

PharmD

PhD

Job description

Regeneron UK Limited is seeking a Manager to join the Global Patient Safety Sciences team in the Uxbridge area. The role focuses on safety strategies for molecules in clinical development and post-marketing phases, including signal detection, evaluation, and DSUR/PSUR/RMP preparation.

The position requires a Master’s degree or higher (PharmD/PhD preferred) with 5+ years in pharmacovigilance or related clinical experience, and strong communication skills for presentations and cross-functional