Medical Device Complaint Reviewer

NURSING DEGREE REQUIRED (BSN or RN or Nurse Practitioner)
The Pharmacovigilance and Patient Safety (PPS) organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand, and communicate the safety profile of Client products to protect patients worldwide. 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 performed under this team: • Assisting with ongoing continuous improvement projects spanning across departmental needs • Providing support for training and automation efforts • Identify regional label variances and build tool to capture info for priority products and main competitors • 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. • Participate in root-cause investigations into device failures and human factors-related use errors. Qualifications Background / Required and Preferred Education Level BSN or RN or Nurse Practitioner Desired Skills: • Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation • Knowledge of Research & 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) • Knowledge of electronic databases (e.g., TrackWise, Business Objects, Oracle, Argus, 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