Career Category

Safety

Job Description Group Purpose: Integrated Signal Management group is responsible for the direction and strategy for safety signal detection and management, safety governance, and quality complaints trending and analytics. It drives policies, research, definition and implementation of innovation and best practices for safety data mining, signal detection planning, management, tracking, product complaints trending and analytics; risk management practices, benefit/risk assessment and safety communications while ensuring quality processes with proven metrics.

Job Summary: The Signal Management and Innovation Lead position leads Amgen safety signal management processes and activities and serves as a key strategic partner within the Integrated Signal Management team, focused on identifying, evaluating, and implementing emerging technologies and AI/ML-enabled analytical tools in collaboration with Data Science, Digital Technology, and AI & Data Science teams. This role will lead the team to bridge scientific, technical, and business functions to co-develop innovative surveillance capabilities that monitor the safety and quality of Amgen products.

Key Activities:

Technology Scouting & Evaluation

• Monitor and evaluate industry trends, emerging technologies, academic research, and vendor solutions related to AI/ML for post-market safety and product complaints surveillance.
• Maintain a landscape of external vendors offering signal detection, NLP, and data analytics solutions relevant to product surveillance.

Collaboration & Innovation Development

• Partner with the ISM Data Science team to assess feasibility, develop prototypes, and deploy AI/ML models for signal detection and augmentation of signal assessment
• Engage with stakeholders (e.g., TA Safety) to identify unmet needs and prioritize use cases.
• Leads AI projects prioritized by GPS
• Facilitate workshops or ideation sessions to shape innovation roadmaps and pilot initiatives.
• Promote adoption of industry best practices and ensure compliance with regulatory guidance on AI/ML and surveillance in the context of combination products.
• Perform regulatory impact and risk analysis of proposed solutions
• Develop internal guidelines and documentation for use of advanced analytics in surveillance activities.

Project Execution

• Lead or support proof-of-concept and pilot initiatives for new surveillance technologies.
• Translate business needs into functional requirements for solution development.
• Track project progress, manage risks, and report findings to senior leadership.

Signal Management

• Responsible for configuration of signal detection activities in Amgen’s signal detection and management system.
• Perform quality control of signal detection and management activities.
• Serve as subject matter expert on Signal management for stakeholders internal and external to Amgen Global Patient Safety.
• Supports inspections and audit activities.
• Train staff on signal management processes and systems.
• Be representative for Health Authority Inspection and internal process audits within the remit of role and responsibility.

People Management

• Manage, mentor, and coach team, fostering a collaborative and product work environment.
• Provide leadership and guidance of team responsibilities to direct report(s).

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