- Perform all tasks as needed by the Safety Systems analyst I & II role
- Support 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).
- Participate and lead Systems support tasks and projects providing technical expertise on PV database (ARISg/ARGUS)
- Good Knowledge of E2B profile logics, customizations
- Ability to develop Database queries, customize and automate activities
- Participate and lead activities related to data management, periodic and ad-hoc reports as needed
- 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.
- Train other team members on systems configurations, business administration and other database related activities
- Monitor / 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
- Partner in the development of system-related training programs and deliver training as needed
- 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
- Train and develop other team members in area of Systems support and database configuration

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
- Solid 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 and others on daily basis
- 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
- Provide guidance to team members in area of routine system maintenance, data management, reports generation and tasks related to special projects/upgrades

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