Safety Reviewer, MDV

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 lives where your purpose accelerates our mission.

Your Role at Baxter

This is where your work saves lives

The research we do and the products we develop improve outcomes for patients around the world. As a Safety Reviewer at Baxter your work contributes directly to making a significant impact on others. Its challenging workand youre not on your own. Our teams collaborate crossfunctionally and lead by influence. Whether guiding a team through a project or managing direct reports our research and development team is responsible for influencing others to achieve results.

Our colleagues within our R&D organization desire to work on products that make a meaningful difference in others lives. We are motivated by the power of teamwork and are natural leaders who are skilled at influencing others.

Your Team

We courage teamwork and collaboration and prioritize building relationships with each other. Its easy to do because we all share common traits of reliability ethical and caring. We lean on our colleagues for their expertise and hold each other accountable.

What youll be doing

• Provide medical review of individual medical device complaints resulting in patient user or thirdparty harm including medical term coding seriousness and Baxter causality assessment.
• Ensures 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 thirdparty 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 Baxters 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 device reporting regulations worldwide (especially FDAs 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.

What youll bring

• Indepth 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 cloudbased collaboration environment ().
• Good analytical and problemsolving skills.
• Excellent oral and written communication and interpersonal skills. Medical writing expertise.
• Ability to adapt and drive constant change for continuous improvement.
• Healthcare professional (RN) preferably with a Bachelors 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 postmarketing safety practices.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating inperson in support of our Mission. The flexible workplace policy is subject to local laws and legal its discretion Baxter may decide to adjust suspend or discontinue as business needs change.

We understand compensation is an important factor as you consider the next step in your career. At Baxter we are committed to equitable pay for all employees and we strive to be more transparent with our pay practices. The estimated base salary for this position is $88000 to $121000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors all of which are subject to change. Individual pay is based on upon location skills and expertise experience and other relevant factors. For questions about this our pay philosophy and available benefits please speak to the recruiter if you decide to apply and are selected for an interview.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

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US Benefits at Baxter (except for Puerto Rico)

This is where your wellbeing matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and wellbeing benefits include medical and dental coverage that start on day one as well as insurance coverage for basic life accident shortterm and longterm disability and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount and the 401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching. We also offer Flexible Spending Accounts educational assistance programs and timeoff benefits such as paid holidays paid time off ranging from 20 to 35 days based on length of service family and medical leaves of absence and paid parental leave. Additional benefits include commuting benefits the Employee Discount Program the Employee Assistance Program (EAP) and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our additional information regarding Baxter US Benefits please speak with your recruiter or visit our Benefits site: Benefits Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

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.