(Senior) Safety Systems Specialist – IQVIA Biotech India (Homebased) 59 views

JOB DESCRIPTION BASIC FUNCTION: Responsible for the configuration and ongoing maintenance of the Argus Safety System and associated modules serves as primary technical support for troubleshooting functionality issues within application and provides

JOB DESCRIPTION BASIC FUNCTION: Responsible for the configuration and ongoing maintenance of the Argus Safety System and associated modules serves as primary technical support for troubleshooting functionality issues within application and provides technical advice related to troubleshooting and other system requests Delivers Safety Management Department services according to ICH-GCP guidelines, regulatory requirements and IQVIA Biotech SOPs and/or project specific procedures. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: Responsible for the configuration and maintenance of Oracle Argus Safety System including: Enterprise creation User maintenance Study design E2B exporting and importing Aggregate Reporting Expedited Reporting Periodic Reporting Liaises with IT and Safety to facilitate timely resolution of system requests Develops and maintains reports related to Safety provides regular updates to Safety team members on status of reporting activities Creates and executes system validation Leads internal and client calls when Safety technical support is required communicates technical information clearly and concisely to non-technical individuals Prepares safety reports for submission to Sponsors, Regulatory Authorities or Investigators Performs project related study close-out and archival tasks Assists management and/or Safety Management Lead in writing Standard Operating Procedures and developing documents related to intake/triage functions, including study-specific processes Assists management in defining and implementing process improvement activities to increase efficiency within the Safety Management department. Mentors and/or trains new Safety staff Performs other duties as assigned by manager. Maintains and further develop Content Management System (CMS) KNOWLEDGE, SKILLS AND ABILITIES: Ability to lead study configuration approaches within the Safety Database to produce desirable outputs at all stages of the study. Ability to read and write PL/SQL Excellent written and verbal communication skills. Positive attitude and proactive approach to interact with all levels of staff and clients to successfully coordinate and execute Safety Management department activities. Excellent organization skills and ability to handle multiple priorities while adhering to applicable timelines. Ability to work independently, develop and follow instructions/guidelines and demonstrate initiative. Basic knowledge of medical terminology. Good knowledge of the clinical research process and current GCP/ICH guidelines applicable to conduct of clinical research. Establishes and maintains effective relationships with customers (internal and external Provides customers with complete and accurate information. Maintains a high energy level when interacting with customers. Acts with the customer in mind. Ability to research and troubleshoot issues independently Ability to work within a matrix team environment required. CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA: Very limited physical effort required to perform normal job duties MINIMUM RECRUITMENT STANDARDS: Bachelor’s Degree, life science or clinical research preferred, plus 3 years of Oracle Argus Safety and pharmacovigilance processing or, equivalent level of education and experience Advanced Computer literacy and experience of working with Microsoft Office (Word, Excel) required. Understanding of Networking and computer languages including Oracle PL/SQL and Visual Basic Ability to work directly within Oracle and MySQL Databases Excellent written and verbal communication skills required. Good interpersonal and organization skills required. CLASSIFICATION (US): This position is classified as exempt employees are not eligible for overtime compensation.

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