Beschreibung
*Drug Safety Database Manager - Zurich*I am working with a market leading pharmaceutical client who are looking for a Drug Safety Database Manager.
They are seeking this consultant on a 12-month assignment, with a more than likely extension to be based out of their office in Zurich.
Responsibilities
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Administration of the Drug Safety database (management and maintenance of database libraries, code lists and user accounts) with the support of the ARIS Global Managed Services team -
Collaborate with ARIS Global Managed Services team (user support, incident management, configuration changes) -
Support database querying activities (requirements definition, reports validation) monitoring the quality of the data outputs and process efficiency -
Support maintenance and enhancements of the applied drug safety systems (e.g. safety database, SharePoint sites, shared drive locations, dedicated mailbox) -
Support the Drug Safety Case Management team in regular process enhancements for better compliance and efficiency -
Support the safety database users (internal and contracted) on technical questions -
Maintain Standard Operating Procedures (business administration, data management) -
Support the appropriate documentation of the drug safety systems and data management -
Support (testing, validation) the implementation of new solutions for drug safety -
Support data cleaning activities
Experience Required
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2-3 years' working experience in drug safety / pharmacovigilance area -
1-2 years' working experience with validated drug safety databases (ARISg preferred), experience with data management is beneficial -
Good knowledge of pharmacovigilance legislations -
Fluency in English -
Excellent user of Microsoft Office (Word, Excel, PowerPoint, Outlook, SharePoint) -
Affinity with Information Technology, quick learner in new applications -
Experience with Business Objects and SQL is preferred -
Experience with computerised systems validations (GAMP 5), Quality Management, procedural documents, compliance metrics, PV training, audits and inspections, CAPA management is beneficial -
Project management training / experience is beneficial
Qualifications
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The ideal candidates is holding a university degree in a Life Sciences field in addition to the following experience: -
Bachelor degree in pharmacovigilance / other life sciences / data management or information systems related sciences (Master degree preferred)
If this is an opportunity is of interest to you, please follow the appropriate links.
Alternatively, if you are a LinkedIn user, please reach out to William Paton at EPM Scientific directly.