Medical Safety Reviewer III
1 week ago
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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