Job
Description
Role Overview: You will be leading the Signal Management and Innovation processes at Amgen, working closely with the Integrated Signal Management team to identify, evaluate, and implement emerging technologies and AI/ML-enabled analytical tools. Your role will involve collaborating with various teams to develop innovative surveillance capabilities for monitoring the safety and quality of Amgen products. Key Responsibilities: - 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. - Partner with the ISM Data Science team to assess feasibility, develop prototypes, and deploy AI/ML models for signal detection and assessment. - Engage with stakeholders to identify unmet needs and prioritize use cases. - Lead AI projects prioritized by GPS and facilitate workshops or ideation sessions to shape innovation roadmaps. - Develop internal guidelines and documentation for the use of advanced analytics in surveillance activities. - Lead or support proof-of-concept and pilot initiatives for new surveillance technologies. - Track project progress, manage risks, and report findings to senior leadership. - Responsible for configuration of signal detection activities in Amgen's signal detection and management system. - Perform quality control of signal detection and management activities and serve as a subject matter expert on Signal management. - Support inspections and audit activities, train staff on signal management processes and systems. - Manage, mentor, and coach team members, providing leadership and guidance on team responsibilities. Qualifications Required: - Bachelor's degree in a relevant field; advanced degree preferred. - Experience in signal management, pharmacovigilance, or related area. - Strong understanding of AI/ML technologies and their application in healthcare. - Project management experience and the ability to lead cross-functional teams. - Excellent communication skills and the ability to collaborate with various stakeholders. - People management experience, fostering a collaborative work environment. Company Details: The Integrated Signal Management group at Amgen is responsible for safety signal detection and management, safety governance, quality complaints trending and analytics, and implementation of innovation and best practices for safety data mining. The team drives policies, research, and risk management practices while ensuring quality processes with proven metrics. Role Overview: You will be leading the Signal Management and Innovation processes at Amgen, working closely with the Integrated Signal Management team to identify, evaluate, and implement emerging technologies and AI/ML-enabled analytical tools. Your role will involve collaborating with various teams to develop innovative surveillance capabilities for monitoring the safety and quality of Amgen products. Key Responsibilities: - 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. - Partner with the ISM Data Science team to assess feasibility, develop prototypes, and deploy AI/ML models for signal detection and assessment. - Engage with stakeholders to identify unmet needs and prioritize use cases. - Lead AI projects prioritized by GPS and facilitate workshops or ideation sessions to shape innovation roadmaps. - Develop internal guidelines and documentation for the use of advanced analytics in surveillance activities. - Lead or support proof-of-concept and pilot initiatives for new surveillance technologies. - Track project progress, manage risks, and report findings to senior leadership. - Responsible for configuration of signal detection activities in Amgen's signal detection and management system. - Perform quality control of signal detection and management activities and serve as a subject matter expert on Signal management. - Support inspections and audit activities, train staff on signal management processes and systems. - Manage, mentor, and coach team members, providing leadership and guidance on team responsibilities. Qualifications Required: - Bachelor's degree in a relevant field; advanced degree preferred. - Experience in signal management, pharmacovigilance, or related area. - Strong understanding of AI/ML technologies and their application in healthcare. - Project management experience and the ability to lead cross-functional teams. - Excellent communication skills and the ability to collaborate with various stakeholders. - People management experience, fostering a collaborative work environment.
