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Amgen
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ISM Innovation Specialist

ISM Innovation Specialist

Amgen

8 - 13 years

11 - 15 Lacs

Hyderabad

Posted:3 days ago| Platform:

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Skills Required

Medical devices Project management Analytical Risk assessment Oncology Natural language processing Pharmacovigilance Risk management Data mining Analytics

Work Mode

Work from Office

Job Type

Full Time

Job Description

Career Category Safety Job Description

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.

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ISM Innovation Specialist