Safety Systems Analyst II
Vernon Hills, IL
Req ID 50803BR
Business Title
Safety Systems Analyst II
Business
Global Quality
Sub-Business
Global Pharmacovigilance
Country
US
State/Province
Illinois
Location of Position
Vernon Hills, IL
Shift_
1st
Job Description
Summary:
This position is a member of Global Pharmacovigilance Reports Management. The Safety Systems Analyst II interfaces with Global IT and is responsible for identifying and defining adequate 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 designing customized/complex database queries and reports for internal and external customers, including regulatory authorities.
Essential Duties and Responsibilities:
*Foster collaboration with GIT to plan and implement system related improvements.
*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 GPV functional areas prior to submission to GIT
*Responsible for verifying, and tracking, complex change requests, including changes to reportability rules, product lists and code lists.
*Coordinate user acceptance testing of system changes implemented by GIT.
*Drive consistent interpretation of system related conventions, specifications, and definitions between GIT and GPV functional areas.
*Partner in the development of Reports Management related processes and SOPs including the PV Safety System User Manual and Data Entry Conventions Manual
*Partner in the development of system-related training programs and deliver training
* Support the generation of complete and accurate periodic reports and ad-hoc reports with technical expertise
*Drive the compilation of Sales Data Reports
*Develop and administer business tools for GPV such as SharePoint sites
* Take initiative to recognize, prioritize & escalate potential safety/ compliance issues
*Serve as an information management escalation contact for downstream users of pharmacovigilance data (Safety Writers, Medical Reviewers, Risk Management, Epidemiology, etc.)
*Interface and collaborate within the scope of these responsibilities:
-with relevant counterparts in the regional and country Pharmacovigilance functions to facilitate the global exchange of safety info
-other functions within PVIM in all aspects of database maintenance with other Baxter groups (e.g. Clinical and Medical Affairs, Quality, Regulatory, IT, Legal, business units, etc)
Job Requirements
Qualifications:
*Excellent technical, analytical and problem solving skills as it pertains to safety database systems
*Strong knowledge of Pharmacovigilance Database (e.g. Oracle AERS, ARISg)
* Strong technical system skills (e.g. word processing, spreadsheet, MS Sharepoint, and databases)
*Strong knowledge of pharmacovigilance terminology and system data entry conventions
*Ability to lead project teams
*Ability to develop and train others
*Excellent oral and written
communication skills
*Excellent interpersonal skills that encourage teamwork
*Excellent attention to detail
*Broad knowledge of relevant ICH guidelines, as well as FDA and EU Regulations
*Strategic Planning and Problem Solving- Identify priorities and key issues in complex situations, and formulate and execute issue resolution with minimal assistance
*Scientific/Technical Analysis : Provide guidance to internal project teams in the area of design and analysis for routine projects
*Product/Process Quality Standards: Maintain currency and compliance with regulatory procedures and systems
Education and/or Experience:
*Bachelor's degree in computer science, life sciences or equivalent
*Minimum of 2 years of previous experience in Systems Management or Safety Data Management .
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
