Global Patient Safety Sciences Manager

Regeneron Pharmaceuticals; Uxbridge; Vor Ort; GBP 70.000 - 110.000; Vollzeit

Zusammenfassung

Regeneron Pharmaceuticals in the United Kingdom is seeking a Manager to join Global Patient Safety Sciences. The role focuses on safety strategies for molecules in development and post-marketing, including data aggregation and safety interpretation.

You will lead signal detection activities, prepare safety documents, and present findings at SMT meetings. A Master level degree or higher and 5+ years of pharma safety experience are required.

Qualifikationen

• Minimum Master degree, PharmD, PhD.
• 5+ years of risk management or relevant clinical experience in pharmaceutical/biotech industry or health authority.
• Clinical experience in the TA of interest is a plus.
• Ability to apply FDA, EU and ICH guidelines governing pharmacovigilance activities.
• Experience with safety systems for medical case review and querying.
• Demonstrates advanced understanding of safety surveillance activities.
• Proactive, self-disciplined with good time management.
• Strong verbal and written safety communication skills.

Aufgaben

• Complete signal detection activities.
• Perform signal evaluation and author safety evaluation reports.
• Manage preparation/review of safety documents (DSUR, PSUR, RMP, responses).
• Prepare and deliver presentations at SMT meetings; participate in clinical study teams.
• Participate in risk management activities for assigned compounds.
• Represent GPS on cross-functional teams (RSOC, IDMC, etc.).
• Manipulate data and create visualizations for safety analysis.
• Contribute to development/maintenance of SOPs, WIs, and supporting docs.

Kenntnisse

Signal detection

Safety data analysis

Data visualization

Regulatory knowledge

Presentation skills

Ausbildung

Master degree / PharmD / PhD

Tools

Excel

Pivot tables

Jobbeschreibung

Regeneron Pharmaceuticals in the United Kingdom is seeking a Manager to join Global Patient Safety Sciences. The role focuses on safety strategies for molecules in development and post-marketing, including data aggregation and safety interpretation.

You will lead signal detection activities, prepare safety documents, and present findings at SMT meetings. A Master level degree or higher and 5+ years of pharma safety experience are required.