6 / 25 / 2019 2 : 01 : 35 AM Baxter International
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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 include, but are not limited to the following :
Supporting the maintenance of current pharmacovigilance safety system (ARISg). 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
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
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability / handicap status or any other legally protected characteristic.
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