This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining liveswhere your purpose accelerates our mission.
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 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
- Perform quality checks both in-line and retrospectively as needed
- May perform case clean-up as required for preparation of aggregate reports
- May participate in compliance monitoring related activities including NCR/CAPA and quality control metrics
- May perform reconciliation activities with organizations within and outside of Baxter
- Train and mentor new hires
Qualifications:- Medical and clinical knowledge
- Excellent analytical and problem-solving skills
- Excellent oral and written communication
- Collaborative interpersonal skills to foster a team environment
- Ability to work independently under strict deadlines and changing priorities
- Ability to multi-task and prioritize changing workload on a daily basis
- In-depth knowledge of worldwide and regional safety regulations
- Ability to establish priorities
- Proficiency in a Global Safety Database (e.g., Argus, ARISg)
- Knowledge of multiple therapeutic areas and source types
Education and/or Experience:- Degree in nursing, pharmacy, science degree or equivalent
- Minimum 3 years of experience in Pharmacovigilance
- 2-3 years of hospital, patient care or equivalent experience preferred
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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