Global Safety Officer (GSO), Global Safety Medical Director - Obesity, US - Remote

Join Amgen's Mission of Serving Patients and be part of something bigger. As a Global Safety Officer (GSO), you will establish the strategy, direction, and priorities of pharmacovigilance activities and be accountable for the overall safety profile and all product-related decisions and deliverables for assigned products.

Requirements

• Validate safety signals and lead safety signal assessments
• Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
• Prepare/review core and regional risk management plans including additional risk minimization measures
• Prepare/review safety sections of periodic aggregate reports
• Provide safety input to protocols, statistical analysis plans, and clinical study reports
• Prepare/review safety sections of new drug applications and other regulatory filings
• Serve as safety expert on Evidence Generation Team for assigned products
• Inspection Readiness

Benefits

• Comprehensive employee benefits package
• Discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible