Get AI-powered advice on this job and more exclusive features. The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical oversight, and initiatives. The team is a high-profile high-impact team that works with PPS functions on a range of product initiatives. As a member of the team, you are at the forefront of working with leaders to identify critical priorities and drive high-value projects that make an impact on safety of our patients. Assisting with ongoing continuous improvement projects spanning across departmental needs Responsible for individual and periodic medical device safety reporting Responsible for PI site notifications Providing support for training and automation efforts Support medical safety consultation activities in matters related to risk/benefit and proper product safety usage as needed. Gain understanding of risk management regulations, standards, and guidance for medical devices and combination products. Job Description The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical oversight, and initiatives. The team is a high-profile high-impact team that works with PPS functions on a range of product initiatives. As a member of the team, you are at the forefront of working with leaders to identify critical priorities and drive high-value projects that make an impact on safety of our patients. Assisting with ongoing continuous improvement projects spanning across departmental needs Responsible for individual and periodic medical device safety reporting Responsible for PI site notifications Providing support for training and automation efforts Support medical safety consultation activities in matters related to risk/benefit and proper product safety usage as needed. Gain understanding of risk management regulations, standards, and guidance for medical devices and combination products. Qualifications Bachelor of Science in Nursing or Bachelor of Science with Major in Nursing Biomedical engineer or RN Required Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation, Case processing of Device SAE/AEs, device complaints and SADE potential cases Knowledge of Research and Development and an understanding of regulatory guidelines / requirements related to R & D Medical Devices / Combination Products (e.g., ICH, GCP, CFR, EU-MDR, safety reporting) Clinical Trial Experience Clinical Trial Device Experience Knowledge of electronic databases (e.g., Rave EDC, Veeva EDC, Microsoft Office including Excel, Oracle, Veeva, Salesforce Applications and other database tools) Ability to effectively interact with and influence others without direct reporting relationships Ability to multi-task and prioritize while maintaining attention to detail with high quality outputs Ability to Meet Challenging Milestones with results orientation Strategic Decision Making and Negotiation Facilitating Change and managing conflicts Ability to Problem Solve Independently and with Others Business Organization and Industry Awareness Cross Functional Relationships and communication skills Execution / Results / Process Improvement Benefits Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics. Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st. Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification. Synectics is an equal opportunity employer. Seniority level Seniority level Entry level Employment type Employment type Contract Job function Job function Science Industries Staffing and Recruiting Referrals increase your chances of interviewing at Synectics Inc. by 2x Get notified about new Reviewer jobs in Chicago, IL . 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