Safety Reviewer, MDV

Baxter International • Batesville, IN

249d • $88,000 - $121,000

About The Position

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.

Requirements

• In-depth 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).
• Good analytical and problem-solving 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 Bachelor's 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 post-marketing safety practices.

Responsibilities

• Provide medical review of individual medical device complaints resulting in patient, user or third-party harm, including medical term coding, seriousness and Baxter causality assessment.
• Ensure 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 third-party 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 Baxter's 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 FDA's 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.

Benefits

• Medical and dental coverage that start on day one.
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount.
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• Flexible Spending Accounts.
• Educational assistance programs.
• Paid holidays and paid time off ranging from 20 to 35 days based on length of service.
• Family and medical leaves of absence.
• Paid parental leave.
• Commuting benefits.
• Employee Discount Program.
• Employee Assistance Program (EAP).
• Childcare benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree