Reviewer, Safety, Medical Device Vigilance

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Overview

This is where new knowledge is discovered. Baxter’s Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives.

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Success Profile

What makes a successful Research and Development team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

Courage
Action Oriented
Collaborates
Cultivates Innovation
Manages Ambiguity
Drives Results

Reviewer, Safety, Medical Device Vigilance

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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.

Overview:

Provide safety (medical) review for individual complaints involving patient harm with the use of Baxter’s medical devices (clinical and spontaneous), including medical term coding, seriousness, expectedness and Baxter causality assessment for an assigned therapeutic area.

Ensure that appropriate medical interpretation and consistency are applied to medical device related adverse event case assessments.

Work with clinical counterparts in the assigned therapeutic area as needed, including, but not limited to, review of serious adverse event handling.

Be an expert for assigned medical devices, maintain current knowledge of full product portfolio and safety profiles for products.

Communicate and interact effectively within and across Therapeutic Teams, and within Functional Team Management as appropriate.

Support the MDV safety signaling process by ongoing monitoring of complaints.

Support internal and external customers related to the evaluation of medical device safety issues and adverse events potentially associated to licensed products safety and performance.

Perform entry and QC peer review of clinical trial data into relevant databases.

Essential Duties:

Provide medical review of individual medical device complaints resulting in patient, user or third party harm, including medical term coding, seriousness and Baxter causality assessment.

Ensure that appropriate medical interpretation, adequate product and therapeutic area knowledge and consistency are applied to device related adverse event case assessments.

Assess the need for additional safety investigation (clinical follow up) and lead the clinical investigation for individual medical device complaints resulting in patient, user or third party harm.

Interact with medical professionals and healthcare facilities to investigate individual cases of device related serious adverse events in accordance and in strict compliance with Baxter's Global Privacy Policy consistent with the Safe Harbor Privacy Principles.

Support the MDV safety signaling process by ongoing monitoring of complaints.

Support internal and external customers related to the evaluation of medical device safety issues and adverse events potentially associated to licensed products’ safety and performance.

Perform clinical trial data entry and QC peer review of clinical trial data into the relevant data processing systems.

Share medical/clinical expertise with counterparts in other functional areas such as quality assurance, regulatory affairs, marketing, manufacturing, and legal globally.

Ensure fast communication of all medical device safety related issues to appropriate stakeholders (MDV Device Safety Physician), including support for the Important MDV Safety Communication.

Maintain knowledge of medical device reporting regulations worldwide (especially FDA’s CDRH and European Commission MDD), risk management standards, and quality management systems.

Contribute to the training, and continuing education for new departmental recruits.

Update Standards of Procedure (SOP) documents as required.

Qualifications:

In-depth knowledge of medical device adverse event processing including triage, investigation, medical assessment and submission to regulatory authorities.

Knowledge and understanding of medical device regulations and regulatory guidelines and/or guidance.

Awareness, and preferably working knowledge, of coding dictionaries (e.g. MedDRA).

Experience with commercial databases and ability to work in an enterprise cloud based collaboration environment (box.com).

Good analytical and problem solving skills.

Excellent oral and written communication and interpersonal skills.

Medical writing expertise.

Ability to adapt and drive constant change for continuous improvement.

Education and/or Experience:

Healthcare professional (RN,) preferably with a Bachelor’s degree in nursing (US only) or equivalent.

At least 5 years of medical professional experience (hospital, patient care, or equivalent experience), including 2 years related clinical, safety or regulatory experience in the medical device industry.

Knowledge of at least two therapeutic areas (Medication Delivery, Nutrition, Surgery, Anesthesia Critical Care).

Experience with multicultural teams, able to manage multiple tasks, and ability to influence in cross functional team setting.

Knowledge and understanding of national and international medical device regulations and regulatory guidelines.

Working relationships with and exposure to various Regulatory Authorities worldwide.

Knowledge of medical aspects of medical device safety, medical device vigilance in pre- and post-marketing safety practices.

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

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Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Reagan, Senior Research Scientist in the United States

“For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference.”

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

“I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world.”

Meet Amitha, Research Associate in India

“Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter.”

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We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.

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Reviewer, Safety, Medical Device Vigilance

Overview

Success Profile

Reviewer, Safety, Medical Device Vigilance

Address

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Hear from Our Employees

Meet Reagan, Senior Research Scientist in the United States

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

Meet Amitha, Research Associate in India

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