Spec, PV

This is where your work makes a difference.

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 withing 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 preferre

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
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