Senior Specialist
1 week ago
Your Job
To provide direct consulting and support for PharmaLex’s Oracle Argus Hosted service, and to provide expertise in Pharmacovigilance and Safety Database systems in general. Provide consulting, training and support on client-facing and internal projects as it relates to the organization’s Argus Hosted service. Assist in designing, developing, implementing, improving, and maintaining technical solutions and service offerings for the Pharmacovigilance business area – in particular with its Argus rapidLIVE package, covering: System setup and configuration.Validation documentation creation, guidance and execution.Training materials development and conduct.Support during implementation and post go-live. Analyse complex business needs presented by clients and the internal community – and recommend & implement solutions. Provide project management and oversight for both client implementation and PharmaLex internal projects. Assist in developing and reviewing pertinent business area-related documents, procedures and working instructions (SOPs, WIs, and FAQs) in support of the Pharmacovigilance area, and ensuring that all activities are in adherence to such defined policies. Deploy version updates, hot-fixes, and patches governed by controlled change request procedures. Participate in designing and executing migrations for Oracle Argus. Contribute with SME expertise to the Business Development process. Any other responsibilities as discussed and agreed to with Supervisor, including any other Platform Technologies strategic initiatives.
Your Profile
At least 3-5 years of experience in the Life Sciences industry, with focus on pharmacovigilance. Bachelor of Science in computer or natural science, or a comparable education. Experience in Oracle Argus technical and functional support. Experience in PL/SQL programming – with general knowledge of database structures/models. In-depth knowledge of computerized software validation (CSV), including GAMP 5 and 21 CFR Part 11. Experience working in GxP governed environments and environments controlled by Information Security Management Systems. Project management experience preferred. Strong communicator fluent in English. Highly organized with strong attention to detail and keen analytical skills – and the ability to efficiently multi-task and handle competing priorities. Ability to work enthusiastically and collaboratively as part of a cohesive group and also independently, as needed. Proactive approach to ensuring continuous improvement and growth for oneself, the Platform Technologies Team, and the PharmaLex organization-
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