Supporting the maintenance of current pharmacovigilance safety system (ARGUS). and other GPS systems
Ability to work flexible schedule 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 valuable understanding of the database structure and application architecture
Robust technical system skills (e.g. Word processing, Excel spreadsheets, Powerpoint, Sharepoint, SQL

📌 Safety Systems Analyst Bengaluru (India)
🏢 Baxter India
📍 India