Associate I Safety Informatics

1. Analyze post-market surveillance data from global sources (e.g., MAUDE, FAERS, EUDAMED, internal complaint databases) to detect safety signals and evaluate adverse event trends.
2. Organize and manage complex datasets using appropriate database systems and data structures.
3. Develop dashboards, visualizations, and summary reports for internal and external stakeholders, including support for regulatory submissions.
4. Collaborate with cross-functional teams including safety physicians, data scientists, and regulatory experts to evaluate post-market safety data.
5. Maintain up-to-date knowledge of regulatory guidelines (e.g., FDA, MDR, ISO 14971) relevant to post-market safety and vigilance.
6. Contribute to the development and improvement of safety signal detection methodologies and tools.
7. Ensure adherence to data privacy, ethics, and compliance regulations in all analyses.

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