Specialist, PV

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.

This position is a member of the Safety Operations Literature team within Global Patient Safety (GPS). This position serves as a subject matter expert for individual case safety reporting both in general and specific to scientific literature. Individuals will perform quality review of work performed by the PV outsource vendor providing instruction and training as needed. This position collaborates with others outside of Safety Operations to review, correct and reconcile data.

Essential Duties and Responsibilities:

• Monitor quality of abstract review, article review, and individual cases processed by PV outsource vendor through random QC of cases or through review of aggregate data.

• Provide training to outsource vendor for Literature review and case processing. This includes overseeing new hire training and certification and ongoing training and feedback for existing vendor staff.

• Process literature adverse event reports as needed as a part of a cross-functional team.

• Interface and collaborate with other organizations within Baxter (e.g., Regulatory Affairs, IT, Legal, Customer Service, etc.) Collaborate with local and regional Patient Safety team members to facilitate the global exchange of safety information.

• Participate in compliance monitoring related activities including CAPA and Quality Control Metrics.

Qualifications:

• 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 strict deadlines and changing priorities

• Able to multitask and prioritize changing workload on a daily basis

• In-depth knowledge of worldwide and regional safety regulations

• Ability to establish priorities for self

• Proficiency in a Global Safety Database (e.g., ARISg, Argus)

• Knowledge of multiple therapeutic areas

• Excellent skills in reading, understanding and assessing scientific literature

Education and Experience:

• RN or Pharmacist

• Experience in pharmaceutical industry- Quality, Pharmacovigilance or Regulatory department

• Minimum 2 years patient care, or equivalent experience AND minimum 1 year experience required as Safety Review Specialist or equivalent position

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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