ISM Innovation Specialist
Location: Hyderabad, India
Job ID: R-218805
Posted On: June 27, 2025
Work Type: On-Site | Full-Time
Category: Safety
About the Role:
Amgen is seeking an ISM Innovation Specialist to join its Integrated Signal Management (ISM) group. This role is focused on pioneering the future of post-market safety surveillance by identifying, evaluating, and implementing advanced technologies—including AI/ML, NLP, and data analytics—to support signal detection, product complaints analysis, and surveillance capabilities across Amgen’s product portfolio.
Key Responsibilities:
Technology Scouting & Evaluation:
Track emerging industry trends, AI/ML technologies, and academic research in safety surveillance.
Maintain an updated landscape of external vendors specializing in signal detection, NLP, and data mining tools.
Analyze feasibility and applicability of innovative tools in the pharmacovigilance/post-market domain.
Collaboration & Innovation Development:
Partner with ISM Data Science to co-develop and prototype AI/ML tools for safety surveillance.
Conduct workshops and ideation sessions to explore unmet needs and shape innovation pipelines.
Ensure innovations align with regulatory guidance for AI in medicinal product safety.
Develop internal documentation, SOPs, and risk assessments for AI/ML tool implementation.
Project Execution & Leadership:
Lead and support proof-of-concept (PoC) and pilot initiatives for new surveillance technologies.
Translate scientific/business requirements into functional system designs.
Monitor progress, report on risks, and deliver innovation updates to stakeholders and senior management.
Required Knowledge & Skills:
Post-market surveillance or pharmacovigilance experience, especially in combination product or device safety.
Familiarity with medical device regulations and safety monitoring standards.
Understanding of software development and AI governance in the pharmaceutical lifecycle.
Experience with market/vendor scanning and technology evaluation.
Preferred Knowledge & Skills:
Hands-on experience with AI/ML, natural language processing, automation, or data mining.
Strong communication and cross-functional collaboration skills.
Proven ability to manage projects and facilitate cross-domain innovation.
Qualifications:
Education & Experience:
8–13 years of relevant industry experience.
Proven involvement in technology-driven safety or post-market innovation projects.
Experience in product/vendor evaluation and/or regulatory-compliant AI application is desirable.
Estimated Salary: ₹35–50 LPA (based on innovation scope and cross-functional leadership role)
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