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Support for the implementation of IDMP in the EU

The project covers Business and Technical Analysis activities to support the implementation of ISO IDMP (Identification of Medicinal Products) in Europe, as part of the Data Harmonization & Interoperability Program (DHI Program).

  • Collect information in scope of IDMP Iteration 1 in Europe, which are not available yet within internal systems (e.g. RIM)
  • The information needs to be collected from source documents (e.g. Module 3, SmPCs), in close collaboration with Regulatory Affairs, CMC… departments and under the supervision of the Data Governance Committee
  • The collected information needs to be aligned and harmonized as per IDMP requirements in the EU, and loaded into the relevant source systems
  • Contribute to the definition of to-be IDMP submission requirements and processes, to support the selection of a submission tool in line with the objectives of the DHI Program
  • Contribute to the integration of the selected IDMP submission tool in the company landscape
  • Contribute to the implementation of the submission tool, including user acceptance testing, training materials, procedures, running-in, support to end users…

Levels, MS Office Suite, Information Needs, Technical analysis, Coaching, Interoperability, Business analysis, ISO Standards, Iteration, European Languages, MS Excel, Technical Business, End User Support, Data Governance, SQL*Plus, Project Management, Logical data model, RIM, Database, Committees, Landscaping, EU regulations, Operations, Regulatory Affairs, Pharmacovigilance, IT, Marketing, GxP, Implementation, CMC

Support for the implementation of IDMP in the EU

Brunel Belgium NV, Brussels
Categories: 
Business Analyst, Business Analyst, Product Manager, Product Manager, IT, Developer, Project Management
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