ISM Innovation Specialist Amgen Technology Private Limited

8.0 - 13.0 years

1 - 8 Lacs

Hyderabad, Telangana, India

On-site

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

Posted 3 weeks ago

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