Medical Devices Adverse Events Reviewer

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. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.

Baxters 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 liveswhere 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 FDAs CDRH and European Commission MDD) risk management standards and quality management systems.

Qualifications and experience crucial for the role:

• Healthcare professional preferably with a Bachelors 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 .

• 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 postmarketing 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.

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