Sr. Specialist PV
Sr. Specialist PV
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Job Description
This is whereyour work makes a difference.
At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.
Here you will find more than just a jobyou will find purpose and pride.
This position is a member of the Safety Operations team within Global Patient Safety (GPS). This position serves as a subject matter expert for individual case safety report processing and/or Quality control for adverse event reports to ensure timely and accurate review processing quality control and reporting.
Essential Duties and Responsibilities include:
Process adverse event reports from a variety of source types (literature or non-literature based on certification) including review and full data entry of adverse event reports determining seriousness expectedness reporters causality and overall event resolution
Ensure that the correct suspect drug was selected within the Pharmacovigilance Safety System
Write narratives summarizing all relevant medical information for individual case safety reports
Code medical terms using standardized medical dictionaries (i.e. MedDRA)
Using medical expertise ensure that all data has been entered and coded correctly in the Global Safety Database
Request case investigation to gather all required medical information including query generation tracking and follow up with reporters in conjunction with local affiliates
Perform quality checks both in line and retrospectively as needed
May perform case cleanup as required for preparation of aggregate reports
May participate in compliance monitoring related activities including CAPA and Quality Control Metrics
May perform reconciliation activities with organizations both within Baxter and outside of Baxter
Train and mentor new hires
Other duties as assigned
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.
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.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself review our Recruitment Fraud Notice.
Required Experience:
Senior IC
Employment Type
Full-Time
