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Safety Systems Analyst

Safety Systems Analyst

ConfidentialBengaluru / Bangalore
30+ days ago
Job description
  • Supporting the maintenance of current pharmacovigilance safety system (ARGUS). and other GPS systems
  • Ability to work flexible hours supporting users in different time zones. May need to work in shifts as needed / assigned.
  • Collaboration with IT teams, Vendor resources to plan and implement system related changes (Routine changes and Change Requests).
  • Initiation, review and notification of routine changes to pharmacovigilance safety system.
  • Review and analysis of user requirements prior to submission and implementation, participate in validation activities as required.
  • Perform periodic review of administrator data including but not limited to user access, company product dictionary and Safety Data Exchange agreements.
  • Ensure that changes made to the databases are controlled through the change control process.
  • Ensure proposed changes to the Pharmacovigilance Safety System are reviewed and validated with GPS functional area prior to processing for implementation
  • Responsible for creating, verifying and tracking complex change requests, including updates to reporting rules, product lists and code lists.
  • Drive consistent interpretation of system related conventions, specifications, and definitions when making any configuration changes
  • Maintain and manage SharePoint sites used for tracking systems requests (Routine changes and Change Requests)
  • Take initiative to recognize, prioritize & escalate potential safety / compliance issues
  • Serve as a backup for the equivalent Data Analyst role as needed to generate complete and accurate reports from the pharmacovigilance safety system
  • Qualifications :

    • Excellent technical, analytical and problem solving skills as it pertains to Pharmacovigilance database systems
    • Strong knowledge of Pharmacovigilance system (e.g. ARISg, ARGUS) with good understanding of the database structure and application architecture
    • Strong technical system skills (e.g. Word processing, Excel spreadsheets, Powerpoint, Sharepoint, SQL and Databases)
    • Strong knowledge of pharmacovigilance terminology and understanding of data entry conventions
    • Excellent oral and written communication skills with attention to detail
    • Excellent interpersonal skills that encourage teamwork
    • Ability to work independently under strict deadlines and changing priorities
    • Ability to multitask and prioritize changing workload for self
    • Broad knowledge / understanding of relevant ICH guidelines, as well as FDA and EU Regulations
    • Problem Solving- Identify priorities and key issues in complex situations, and formulate and execute issue resolution with minimal assistance
    • Skills Required

      Databases, Pharmacovigilance, Systems Management, Data Management

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