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 lives—where your purpose accelerates our mission.
Job Summary
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.
What you'll be doing
- 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 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 accurately 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
What you'll bring
- Degree in nursing, pharmacy or science degree or equivalent.
- 3 years of experience in Pharmacovigilance.
- 2-3 years hospital, patient care, or equivalent experience preferred Medical and clinical knowledge
- Excellent analytical & problem-solving skills
- Excellent oral and written communication
- Collaborative interpersonal skills to foster a team environment
- Ability to work independently under deadlines and changing priorities
- Able to multitask and prioritize changing workload every day
- In-depth knowledge of worldwide and regional safety regulations
- Ability to establish priorities *Proficiency in a Global Safety Database (e.g., ARISg, Argus)
- Knowledge of multiple therapeutic areas and case source types First list the minimum requirements for the role
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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