*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
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
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
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.