Spec, PV

This position is a member of the Safety Operations team within Global Patient Safety (GPS). The role involves individual case safety report processing and acting as a case owner for adverse event reports. Key responsibilities include timely and accurate review, processing, quality control, and reporting of adverse events. The individual will process reports from various sources, determine seriousness and causality, write narratives, code medical terms, and ensure data accuracy within the Pharmacovigilance Safety System.

Must Have

• Process adverse event reports from all source types
• Review and fully data enter adverse event reports
• Determine seriousness, expectedness, reporter’s causality, and overall event resolution
• Ensure correct suspect drug selection in the Pharmacovigilance Safety System
• Write narratives summarizing medical information for individual case safety reports
• Code medical terms using standardized medical dictionaries (e.g., MedDRA)
• Ensure data entry and coding correctness using medical expertise
• Request case investigation, including query generation, tracking, and follow-up
• Possess medical and clinical knowledge
• Demonstrate excellent oral and written communication
• Operate effectively in a team environment
• Work independently under strict deadlines and changing priorities
• Multi-task and prioritize changing workload daily
• Have working knowledge of worldwide and regional safety regulations
• Establish proficiency in the Pharmacovigilance Safety System

Good to Have

• Experience in the pharmaceutical industry (Regulatory or Safety)
• 2-3 years of hospital, patient care or equivalent experience

Job Description

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 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.

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