Spec, PV
Baxter International
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At Baxter, we believe every person—regardless of who they are or where they are from—deserves 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 job—you 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 team member for individual case safety report processing and as case owner for adverse event reports to ensure timely and accurate review, processing, quality control, and reporting.
Essential Duties and Responsibilities:
Process adverse event reports from all source types including review and full data entry of adverse event reports determining seriousness, expectedness, reporter’s causality and overall event resolution
Ensure that the correct suspect drug is 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 (e.g., MedDRA)
Using medical expertise, ensure that all data has been entered and coded correctly in the database
Request case investigation to gather all required medical information, including query generation, tracking and follow up with reporters in conjunction with local affiliates
May perform quality checks as requested/necessary
May perform case clean-up as required for preparation of aggregate reports
Qualifications:
Medical and clinical knowledge
Excellent oral and written communication
Operates effectively in a team environment
Ability to work independently under strict deadlines and changing priorities with some supervision
Ability to multi-task and prioritize changing workload on a daily basis
Working knowledge of worldwide and regional safety regulations
Ability to establish proficiency working in the Pharmacovigilance Safety System
Education and/or Experience:
Degree in nursing, pharmacy, science degree or equivalent
Experience in the pharmaceutical industry (Regulatory or Safety) preferred
2-3 years of hospital, patient care or equivalent experience preferred
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.
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