Safety Data Analyst
Vernon Hills, IL
Req ID 48689BR
Business Title
Safety Data Analyst
Business
Global Quality
Sub-Business
Global Pharmacovigilance
Country
US
State/Province
Illinois
Location of Position
Vernon Hills, IL
Shift_
1st
Job Description
This position is a member of Global Pharmacovigilance Data Management team. The Safety Data Analyst I is responsible for ensuring that information entered and retrieved from the databases is consistent and accurate. This position is responsible for handling queries and generating complete and accurate reports for internal and external customers, including regulatory authorities.
The responsibilities include, but are not limited to the following:
•Generate complete and accurate periodic reports and ad-hoc reports
•Standardize queries to ensure consistency of reports generated
•Collaborate with the report requester to assure accurate interpretation of the data request
•Ensure timely completion and distribution of regulatory reports and query requests
•Serve as a data integrity escalation contact for downstream users of Pharmacovigilance data (Safety Writers, Medical Reviewers, Risk Management, Epidemiology, etc.)
•Ensure consistent interpretation of system related conventions, specifications, and definitions between GIT and GPV functional areas
•Collaborate with Safety Systems Analysts and GIT to plan and implement system related improvements regarding queries and report generation. Support may include planning, testing, piloting.
•Take initiative to recognize, prioritize & escalate potential safety/ compliance issues
•Identify and troubleshoot root causes of thematic data integrity issues
•Identify potential errors and omitted data found during query and address them for review to the responsible user
•Participate in the development of system-related training programs in support of data integrity initiatives
•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 Pharmacovigilance in all aspects of data management with other Baxter groups (e.g. Clinical and Medical Affairs, Quality, Regulatory, IT, Legal, business units, etc)
Job Requirements
•Working knowledge of Pharmacovigilance terminology and system data entry conventions preferred
•Understanding of data structure of PV database preferred
•Technical, analytical and problem solving skills as it pertains to database management
•Strong organizational skills with strong attention to detail
•Excellent written and oral communication skills
•Operates effectively in a team environment
•Technical system skills (e.g. word processing, spreadsheet, MS SharePoint)
•Knowledge of medical and clinical terminology
•Knowledge of relevant ICH guidelines, as well as FDA and EU Regulations preferred
•Strong attention to detail
•Strategic Planning and Problem Solving: Analyze and process adverse event and safety reports with utmost quality and timeliness
•Submission/Project Management: Assist or lead the preparation of AE reports
•Communication with Regulators/Customers: Provide technical expertise in meetings with internal and external Customers
•Bachelor's degree in scientific discipline, life- or computer science or equivalent
•One year of previous experience in Data Management or related area
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.
