Baxter Life Sciences Analyst Post – BSc Candidates Apply Online
BSc candidates with a life sciences background are encouraged to apply online for Safety Systems Analyst vacancy at Baxter. Baxter is hiring bsc life sciences candidates for a Safety Systems Analyst vacancy. Interested and eligible candidates, check out all of the details on the same below:
Name of Job: Safety Systems Analyst
Req Number: JR – 000559
Location: Karnataka, KA IN
Job Category: GST Operations
Round the world, our workers are united with our mission to save and sustain lives. Together, we create a culture which encourages colleagues to pursue rewarding careers — in which everyone has the opportunity to perform meaningful work as part of a team they respect, in an environment which values each person’s contributions. We are happy you are interested in continuing your career journey with Baxter.
This position is a member of the Global Patient Safety (GPS) — Technology, Systems Support team. This position is responsible for managing systems and databases to support consistent and accurate pharmacovigilance data collection, data analysis, report generation, and submission tracking. This role implements user needs and acts as a technical expert for managing system requests and updates to code lists and libraries. This position works with internal GPS functional areas in addition to vendor resources to review and implement medium to complex change requests such as updates to reporting rules.
Obligations include but are not Limited to the following:
- Supporting the upkeep of current pharmacovigilance safety system (ARISg). Along with other GPS systems
- Ability to work flexible hours supporting users in different time zones. Might need to work in shifts as needed/assigned.
- Collaboration with IT teams, Vendor resources to plan and implement system related changes (Routine alterations and Change Requests).
- Initiation, notification and review of routine changes to the pharmacovigilance safety system.
- Review and analysis of user requirements before submission and implementation, participate in validation actions as required.
- Perform periodic review of administrator data including but not restricted to user access, company product dictionary and Safety Data Exchange Agreements.
- Ensure that changes made to the databases are controlled via the change control process.
- Ensure proposed changes to the Pharmacovigilance Safety System are reviewed and validated with GPS operational area before processing for implementation
- Responsible for creating, verifying and tracking complex change requests, such as updates to reporting rules, product listings and code lists.
- Drive consistent interpretation of system related conventions, specifications, and definitions when making any configuration changes
- Maintain and manage SharePoint sites utilized for tracking systems asks (Routine changes and Change Requests)
- Take initiative to recognize, prioritize & escalate potential safety/ compliance issues
- Serve as a backup for the equal Data Analyst role as needed to generate accurate and complete reports from the pharmacovigilance safety system
- Excellent technical, analytical and problem-solving abilities when it pertains to Pharmacovigilance database systems
- Strong Understanding of Pharmacovigilance system (e.g. ARISg, ARGUS) with great
- Comprehension of the database structure and application architecture
- Strong technical system abilities (e.g. Word processing, Excel spreadsheets, Powerpoint, Sharepoint, SQL and Databases)
- Strong Understanding of pharmacovigilance terminology and Comprehension of data entry conventions
- Superb oral and written communication skills with attention to detail
- Superb interpersonal abilities that encourage teamwork
- Capability to work under strict deadlines and changing priorities
- Ability to multitask and prioritize changing workload for self
- Broad knowledge/understanding of applicable ICH guidelines, in Addition to FDA and EU Regulations
- Problem Solving- Identify priorities and key issues in complex situations, and formulate and execute issue resolution with minimal assistance
Education / Expertise:
- Bachelor’s degree in computer science, life sciences or equal
- Minimum of 1-2 years of previous experience in Pharmacovigilance Systems
- Management or Data Management or related area
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