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新着求人 DM  (DM-10)
募集職種 外資系製薬企業の Japan System Support and Data Management (SSDM) Manager
勤務地 東京
会社概要 非公開
求人要件 ・In-depth understanding of pharmacovigilance processes, regulatory compliance and needs of standardization.
・Knowledge of GCP and validation of computerized system methodology.
・Knowledge on a query tool (BI, Business Objects, OBIEE) desirable
・Previous experience working with Argus safety database
・Previous experience in computerized system methodology for implementation and validation of IT systems
・Resource management. To manage/coordinate the workload of staff to ensure productivity and efficient use of resources to meet the immediate needs of the group for projects or daily base business. In addition to supporting the workload needs
Participate in discussions with Safety Experts to develop strategy for designing AE database searches.
・Proactive approach that should increase the efficiency of the development and validation process and shorten cycle time.
・Interface with users to ensure understanding of the request, suggest strategies for handling the request, and provide target date for delivery of the report. This will allow for efficient handling of requested ad hoc or standard reports and allow for timely delivery of these reports to meet department needs.
・Responsible for working with end users and GPE to define business requirements for the system or related sub systems. Responsible for troubleshooting system issues as they arise and working with the ITS departments to ensure rapid resolution of the problem.
・Develop ad hoc and standard queries and reports (SQL, variable reports, BI or Business Objects) according to the user requirements, database model and data entry conventions. This will allow use of current technology to meet the needs of the users to allow them to be able to effectively obtain the data they need for decision making purposes.
・Provide validation of reports generated by the Ad Hoc Reporting specialist prior to release. Ensure the accuracy of the data included in reports as these are used to support the safety of our products with regulators.
・Develop change control documents and test scripts to be used for validation. Ensure consistent, reproducible results in the validation process.
・Interface with IT department to ensure that user requirements are understood prior to system development. This will allow for consistency in the final system deliverables and ensure consistency with the desires of the users. Generate PUMA documents required for system development in particular requirements specification, validation strategy and user acceptance testing. These documents are needed for the development/maintenance of computerized systems to ensure the conformity of the system with the end users requirements
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