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 PSEQ 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.

Experience & Skills:

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., TrackWise, Business Objects, Oracle, Veeva, Argus, EDC Rave, Veeva EDC 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

Core Essential Skills:

Background / Required and Preferred Education Level:

Job Types: Full-time, Contract

Pay: Up to $51.93 per hour

Expected hours: 40 per week

Benefits:

Schedule:

Education:

Experience:

Work Location: Remote

Tellus Solutions

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