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About the Role

Serve patients worldwide by executing Amgen’s pharmacovigilance processes. This role is part of a global team responsible for the safety oversight of Amgen's combination products, ensuring high-quality, compliant end-to-end case management processes.

Responsibilities

• Act as US/EU local safety office and FDA/EMA point of contact for safety reporting
• Submission of all individual case safety reports to FDA/EMA, and interactions support with business partners (license partners) and vendors for all case intake and processing activities
• Vendor oversight of all case intake processing activities and case quality including analysis and reporting of trends in quality measures
• Ensure vendor compliance with approved processes and training requirements
• Audit & external inspection support
• Oversee ICSR processing, vendor performance, training, quality and compliance
• Manage key business partner relationships
• Support inspections and audits
• Help lead case management operations and team activities to ensure global regulatory compliance

Requirements

• Degree educated and direct related experience in PV
• Previous experience directly managing teams, projects, programs or directing the allocation of resources
• Case Processing & Management with a strong preference for experience in combination/devices
• Vendor Management experience including on-boarding and ongoing training support and performance monitoring and metrics distribution
• Understanding of global regulatory requirements for pharmacovigilance
• Experience in supporting inspections or internal audits

Skills

• Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook
• Competence in safety systems

Location

• Cambridge
• Uxbridge

Work Type

• Hybrid

Experience Level

• Experienced professional

Education Level

• Degree educated

Benefits

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

About the Company

• Amgen is one of the world’s leading biotechnology companies.
• We are global collaborators who achieve together—researching, manufacturing and delivering ever-better products that reach over 10 million patients worldwide.

Equal Opportunity

• Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
• We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.