Job Description

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. Activities: 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. Biomedical engineer or RN Required. Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8-hour day). Responsibilities: Medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. May manage the activities of regional contract CRAs, and organize the files and budgets associated with several clinical studies. Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and Client community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. Off-label information would be disseminated at this level. May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification. Requirements: Bachelor's degree in nursing required or higher with minimum 3-4 years' experience in the medical device industry required. Minimum 5 years direct patient care as a Registered Nurse preferred. Expert level of understanding of global Medical Device regulations such as FDA, EU-MDR and other guidelines affecting device safety issues. Sound understanding and application of device risk management and associated risk management documents such as Clinical Hazards List, Application Failure Mode and Effects Analysis, System Risk Analysis etc. Excellent critical thinking and application skills required. Ability to speak up and support medical device safety analytics team in meetings and explain position of the clinical team. Able to apply clinical knowledge and expertise to adverse event data and perform safety assessment. Competent in ability to present device safety event data, orally and in writing. Adheres to policies and regulations. Must be Computer proficient (Windows, Word, Excel). Katalyst Healthcares and Life Sciences

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