
Medical Product Surveillance Specialist
7 days ago
Job Description
Key Activities- Monitor and evaluate emerging industry trends, technologies, academic research, and vendor solutions related to AI/ML for post-market surveillance.
- Maintain a landscape of external vendors offering signal detection, NLP, and data analytics solutions relevant to product surveillance.
- Partner with the 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 in combination products.
- Perform regulatory impact and risk analysis of proposed solutions.
- Develop internal guidelines and documentation for advanced analytics in surveillance activities.
- 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.
Required Skills and Qualifications
- Post-market surveillance experience, pharmacovigilance, medical device vigilance, or related domain knowledge.
- Combination products and medical devices knowledge, including device safety monitoring regulations and standards.
- Software development concepts understanding.
- Market scanning, vendor/product evaluation experience.
- Regulatory framework and guidance on AI in medicinal products lifecycle knowledge.
Preferred Skills and Qualifications
- Demonstrated experience working with or evaluating AI/ML tools, safety analytics, NLP, or data mining.
- Strong project management, cross-functional collaboration, and communication skills.
Education and Experience
- 8-13 years of industry experience.
- Experience with market scanning, vendor/product evaluation.
- AI/ML and/or automation tools experience.
- Strong project management, cross-functional collaboration, and communication skills.
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