Arlington Heights, IL, 60004, USA
2 days ago
PV Argus Business and System Contractor
PV Argus Business and System Contractor Job Number: 352080 Category: Pharmaceutical Description: Job Title: PV Argus Business and System Contractor Location: Arlington Heights, IL Start Date: Right Away Keywords: #PharmacovigilanceSpecialist Job Description: Support PV Systems and Operations Team in optimizing case processing and global adverse event database (GAED) functionality. The individual will support the Argus Safety system, work with the Client team and the hosting vendor and ensure that requests for system issues, enhancements and other system changes are resolved in a timely manner. Essential Responsibilities: * Work on day-to-day operations with the hosting vendor and managing SLAs (service level agreements) to ensure that outstanding tickets are resolved in a timely manner. * Works with PV Case Processing team to troubleshoot Case Processing and E2B reporting issues. * Serves as Argus business administrator and completes tasks including safety database queries, database maintenance and validation activities. * Manages and tracks the status of system change requests, enhancements and/or support efforts. * Support implementation of safety system enhancements and upgrades, including (but not limited to) involvement in project workshops, CRP testing, Dry Runs, UAT execution, Cutover and Post Go-live support. * Troubleshoots root cause of data discrepancies and use those findings to improve case processing efficiencies. * Contributes to testing of new system configurations * Reviews and performs impact assessment for requested changes * Gathers and documents user requirements for adhoc and custom reports * Perform adhoc queries of the database and work with vendor as needed to develop validated queries/reports * Maintains database user manual and safety system training materials * Contribute as needed in inspections and audits, including delivering database queries * Process ICSRs (data entry, QC, finalization and distribution) as required. Qualifications/Requirements * Bachelor"s degree in a Life Sciences discipline, Nursing or Pharmacy * 5+ years" experience working within the Drug Safety/ Pharmacovigilance/Consulting domain including case processing experience, user requirements gathering and user acceptance testing. * At least 3 years of pharmacovigilance systems experience. * Extensive experience with Argus Safety database including experience with Argus Console, creating advanced conditions and generating reports and listings in Argus. * Ability to work in Eastern Time Zone * Experience with managing hosting vendor. * Strong knowledge of rules and regulations applicable to the Global Safety industry. * Attention to detail, results-oriented and persistent with excellent organizational skills. * Self-motivated and ability to work independently in a fast-paced environment, prioritize multiple tasks and ability to recognize time sensitivity. * Experience with full case processing workflow (e.g., assessing & triaging cases, data entry, quality check/review, follow up letter generation and submissions). * Ability to adapt to constant change and influence positive change effectively. * Team-oriented and responsive to customer needs. * Ability to understand technical documentation and execute associated procedures. * Act as Business System Administrator for the Global Computer System for Adverse Events (GCSAE) and as company contact for MedDRA subscription. Directs system development, maintenance and validation, in cooperation with the Global IT Department QMS & R&D QA QMS. If you are interested in this role, please apply via the apply now link provided. Our overriding goal is to provide quality staffing solutions that help people, organizations, and communities succeed. Belcan is a leading provider of qualified personnel to many of the world's most respected enterprises. We offer excellent opportunities for contract, temporary, temp-to-hire, and direct assignments. We are the employer of choice for thousands worldwide. For more information, please visit our website at Belcan.com EOE/F/M/D/V Location: Arlington Heights , IL Minimum Experience (yrs): 5+ Required Education: Not Specified Benefits: Return to search results Email this job to a friend (emailjobs.asp?jo_num=352080) If you have previously registered with us, pleaseLog in (memberlogin.asp) to apply for this position. *Logged in members may also add jobs to their job cart
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