Medical Safety Reviewer III

1 week ago


North Chicago, United States Randstad Life Sciences US Full time

1 Year Contract

REMOTE


PR:

Zone 0 - $41-46/hr

Zone 1 - $40-45/hr

Zone 2 - $47-52/hr

Zone 3 - $49-54/hr


Zone 0 - All physical and virtual locations in IL, MI, OH, and other states, excluding physical and virtual locations in TX, MA, NJ, NY and CA

Zone 1-- All physical and virtual locations in Texas (TX)

Zone 2-- All physical and virtual locations in MA, NJ, NY, CA (excluding: physical locations in

Campbell, South San Francisco, Dublin, Livermore and Pleasanton)

Zone 3-- Only CA physical locations of Campbell, South San Francisco, Dublin, Livermore and Pleasanton


Summary:

  • 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
  • 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

  • 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 & 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



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