ISM Innovation Specialist

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