| Application Development- drug labeling and medical devices processes at Remote, Remote, USA |
| Email: [email protected] |
| From: priyanka verma, Triwave Solutions Inc [email protected] Reply to: [email protected] Application Development and Operational Maintenance--Health Care Domain Implement and optimize daily drug labeling and medical devices processes. Understand marketed drugs in the United States, Structured Product Labeling information (package inserts), and the FDA product code/system. Understand, implement, and troubleshoot Drug indexing files, such as Pharmacologic Class Indexing files, Billing Unit Indexing files, Product Concept Indexing files, 3 Biologic or Drug Substance Indexing files, Substance Indexing files, Warning Litter Alert Indexing files, and similar data. Deep knowledge of the FDA Risk Evaluation and Mitigation Strategies (REMS) and how to implement the REMS indexing files process. Understand the relationship between Structured Product Labeling system and RxNorm (a normalized naming system for generic and branded drugs) and implement mapping and support. Understand the Global Unique Device Identification Database and Unique Device Identifiers. Implement and provide production support APIs for Medical Device information, Medical Device History, Medical Device Recall, Lookup Medical Devices, and similar data. Understand SNOMED information and GMDN information. Implement and provide production support for API to retrieve a single device's associated SNOMED information by using UMLS User Ticket. Understand Medical Device data and implement/support search functionality for basic/advanced search to retrieve attributes related to medical devices. Deep knowledge and provide customer support on using UDI standards and issuing agencies format such as GS1, HIBCC and ICCBBA Understanding of United Nations Standard Products and Services Code (UNSPSC) database and its integration with healthcare datasets to be able to resolve users issues and answer users inquiries. Serve as technical expert to be able to troubleshoot any production related problems; answer public users questions about labeling and medical devices, communicate with the FDA to provide technical guidance and discuss topics such as process flow and schema changes, and engage in walkthroughs with researchers, vendors, and/or the FDA to identify potential issues and solutions. Provide technical support for FDA Product Code database and its integration with other terminology services. Deeper knowledge in using MESH RDF and GraphQL database for production support. Keywords: Application Development- drug labeling and medical devices processes [email protected] |
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| Tue Jun 11 17:06:00 UTC 2024 |