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Involved in providing a high level of expertise to retrieve data and
prepare complex outputs from the Pharmacovigilance database to support
the analysis of drug Pharmacovigilance related tasks. - Use their
experience of pharmacovigilance data management to mentor, train and
deliver a high level of expertise during approval of activities to other
data managers. - Identify process improvements and lead data management
related activities. - Contribute in ensuring harmonization in the
retrieval of data and in the preparation of outputs from the
Pharmacovigilance database to support the analysis of drug
Pharmacovigilance related tasks.
Support other Pharmacovigilance Data Managers and DS&E customers or other external line units by providing a high level of expertise concerning the definition and/or implementation of Complex retrievals. Perform QC check on complex data retrieved; Identify errors/inconsistencies in outputs and resolves them or initiates their resolution. Provide input and review database design, validation checks and necessary reports to ensure high quality and consistent data during retrievals. Coach, train and mentor new Pharmacovigilance Data Management personnel as appropriate. Act as the business lead for assigned DS&E data management activities. Proactively identifies opportunities for improvement and harmonization of Pharmacovigilance Data Management and DS&E business processes and proposes and implements new solutions. Involved in testing and validating activities to support operational change requests and DS&E IT projects. Assist Department Head in defining Pharmacovigilance data management strategy and guidelines in order to establish common rules for assessing adverse event reports. Assist and deputize for the Pharmacovigilance Data Management Head as appropriate. Assist Pharmacovigilance Data Management Head in writing procedural documents as appropriate.
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