Safety Systems Analyst

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

Summary

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 requirements and acts as a technical expert for managing system requests and updates to codelists and libraries. This position works with internal GPS functional areas as well as vendor resources to review and implement medium to complex change requests including updates to reporting rules.

Responsibilities

Responsibilities include, but are not limited to the following:

• 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
   

Education / Experience:

• Bachelor's degree in computer science, life sciences or equivalent
• Minimum of 1-2 years of previous experience in Pharmacovigilance Systems Management or Data Management or related area

Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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