Ism Innovation Specialist

Career Category Safety Join Amgen s Mission of Serving Patients At Amgen if you feel like you re part of something bigger it s because you are Our shared mission to serve patients living with serious illnesses drives all that we do Since 1980 we ve helped pioneer the world of biotech in our fight against the world s toughest diseases With our focus on four therapeutic areas -Oncology Inflammation General Medicine and Rare Disease- we reach millions of patients each year As a member of the Amgen team you ll help make a lasting impact on the lives of patients as we research manufacture and deliver innovative medicines to help people live longer fuller happier lives Our award-winning culture is collaborative innovative and science based If you have a passion for challenges and the opportunities that lie within them you ll thrive as part of the Amgen team Join us and transform the lives of patients while transforming your career 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 Innovation Specialist will serve as a key strategic partner within the Signal Management and Post-Market Surveillance Trending organization focused on identifying evaluating and implementing emerging technologies and AI ML-enabled analytical tools in collaboration with the ISM Data Science team This role will 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 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 Knowledge and Skills Required Knowledge and Skills Experience in post-market surveillance pharmacovigilance medical device vigilance or related domain Knowledge of combination products and medical devices including device safety monitoring regulations and standards Knowledge of software development concepts Experience with market scanning vendor product evaluation Knowledge of regulatory framework and guidance of principles for AI in the medicinal product lifecycle Preferred Knowledge and Skills Demonstrated experience working with or evaluating AI ML tools safety analytics natural language processing NLP or data mining Strong project management cross-functional collaboration and communication skills Education Experience 8-13 years of industry experience Experience with market scanning vendor product evaluation Experience working with AI ML and or automation tools Strong project management cross-functional collaboration and communication skills What you can expect from us As we work to develop treatments that take care of others we also work to care for your professional and personal growth and well-being From our competitive benefits to our collaborative culture we ll support your journey every step of the way In addition to the base salary Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards Apply now for a career that defies imagination Objects in your future are closer than they appear Join us careers amgen com As an organization dedicated to improving the quality of life for people around the world Amgen fosters an inclusive environment of diverse ethical committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients Together we compete in the fight against serious disease Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability status or any other basis protected by applicable law We will ensure that individuals with disabilities are provided with 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 accommodation