Medical Devices Adverse Events Reviewer

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Overview

As a member of Baxter’s sales team, you’ll be aligned to one of our global business units and be responsible for new business, developing existing accounts and ensuring patient-centric approach in all your dealings. You’ll work within an assigned geographic area or with specific accounts to achieve or exceed personal and business goals, all in pursuit of our mission to save and sustain lives. In the sales role, you’ll have the opportunity to provide input on new markets and products, manage customer concerns, and collaborate with other teams.

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 Sales Professional at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

Stakeholder Insight and Influence
Sales Solution Identification and Development
Negotiation Skills
Strategic Planning
Managing and Coaching
Ownership of the Business

Medical Devices Adverse Events Reviewer

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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.

Summary

Conduct safety reviews for patient harm complaints involving Baxter medical devices, applying medical interpretation and consistency to adverse event (AE) case assessments. Collaborate with clinical counterparts and maintain expertise on assigned medical devices, communicating effectively within and across teams to support medical device safety signaling. Evaluate medical device safety issues and adverse events for licensed products, and perform data entry and quality control peer review of clinical trial data.

What will you be doing?

Providing medical review of individual medical device complaints resulting in patient, user or third party harm.
Ensuring that appropriate medical interpretation, adequate product and therapeutic area knowledge and consistency are applied to device related adverse event case assessments.
Assessing the need for additional safety investigation (clinical follow up) and leading the clinical investigation.
Supporting the MDV safety signaling process by ongoing monitoring of complaints.
Ensuring fast communication of all medical device safety related issues to appropriate collaborators.
Maintaining knowledge of medical device reporting regulations worldwide (especially FDA’s CDRH and European Commission MDD), risk management standards, and quality management systems.

Qualifications and experience crucial for the role:

Healthcare professional, preferably with a Bachelor’s degree in nursing, paramedic, or pharmacy technician.
At least 5 years of medical professional experience (hospital, patient care, or equivalent experience), including 2 years related clinical, safety, pharmacovigilance or regulatory experience in the medical device industry.
Proficient English.
Good analytical and problem solving skills.
Excellent oral and written communication and interpersonal skills.

Nice to have qualifications and experience:

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).
Knowledge of at least two therapeutic areas (Medication Delivery, Nutrition, Surgery, Anesthesia Critical Care).
Experience with multicultural teams.
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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Bucharest
Bucureşti
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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 Andrea – after joining Baxter as a Customer Service Specialist, Andrea was promoted last year to Territory Manager.

“Baxter’s culture is one of inclusivity, respect and acceptance for one another, regardless of religious, political or sexual orientation. There is immense support that starts all the way at the top of the organization, including the creation of “Best Place to Work” for all employees.”

Meet Paula – she has been with Baxter for 17 years and works as a Sales Specialist in Ireland.

“In Baxter we are encouraged to extend our competencies and experiences through ongoing feedback, experiences and regular training. Personal development to achieve career aspirations is actively encouraged, and as a result, I recently secured an internal promotion which was actively supported by my manager and the wider Baxter team.”

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Medical Devices Adverse Events Reviewer

Overview

Success Profile

Medical Devices Adverse Events Reviewer

Address

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Hear from Our Employees

Meet Andrea – after joining Baxter as a Customer Service Specialist, Andrea was promoted last year to Territory Manager.

Meet Paula – she has been with Baxter for 17 years and works as a Sales Specialist in Ireland.

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Join Our Talent Community