Drug Safety Specialist

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.

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.

• 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%)