Global Channel Management is a technology company specializing in recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience across various verticals. GCM understands the challenges companies face regarding skills and experience needed to fill day-to-day functions. Organizations aim to reduce training and labor costs while acquiring top talent. Qualifications The Drug Safety Specialist position requires 5-7 years of experience in Cognos report development and project management, preferably within the pharmaceutical industry. The candidate must have: Experience working with validated applications is preferred. Understanding of Oracle business applications and reporting tools, including web-based and client-server applications in an Oracle Argus, Internet/Intranet, Cognos environment. Familiarity with Crystal Reports, SAS, and Empirica is preferred. Working knowledge of CFR Part 11 is essential. Familiarity with ICH and GxP guidance and regulations. Drug Safety Specialist duties include: Creating advanced reports using Cognos, SQL, Argus reporting, Adobe Acrobat, MS Excel, and other tools for aggregate reporting, safety data surveillance, data mining, and risk management. (30%) Managing internal and external projects and vendors, setting up project plans, and ensuring adherence to timelines. (30%) Experience in pharmacovigilance safety data processing and using Oracle's Adverse Event Reporting System (Argus) or similar applications for tracking drug safety data, contributing to report design and system testing. (20%) Supporting documentation, testing, and validation of reports and functionalities of Argus and Cognos, along with process improvement and SOP and WI writing. (20%) #J-18808-Ljbffr
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