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.

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.

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.