Medical Devices Adverse Events Reviewer

Apply Now

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

Medical Devices Adverse Events Reviewer

Apply Now

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.

We offer:

Fixed-term contract for 3 months and then for an indefinite period.
Competitive salary, annual bonuses, recognition award program.
Culture based on our values: collaboration, speed, courage and simplicity.
Possibilities for development on a personal and professional level in one of the leading global MedTech companies.
Package of benefits including Private medical care (Lux Med), Life Insurance, Multisport card.
Bax4U - cafeteria/lunch cards (300 PLN).
PPE program with very attractive conditions available for each employee after 3 months.
Educational support: fully covered language courses (English or other languages according to business needs), financial certifications (ACCA, CIMA).
Co-financing of holidays and an additional 2 days off from work annually.
Day off for birthday!
Employee Stock Purchase Plan.
Bax Flex - hybrid model.
Phenomenal Warsaw office location - Powiśle!

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.

Apply Now

Address

Explore this location 8 Kruczkowskiego Street
00-380 Warsaw
Masovian
Poland Explore This Location

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.”

Join Our Talent Community

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.

Join Now

Medical Devices Adverse Events Reviewer

Overview

Success Profile

Medical Devices Adverse Events Reviewer

Address

Share

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

Related Content

Join Our Talent Community