Job Title : Medical Device Safety Analyst 
Location:100% Remote 
Duration: 12 Months
 
 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:
Ability to Meet Challenging Milestones with results orientation – Skilled
Strategic Decision Making and Negotiation – Skilled
Facilitating Change and managing conflicts – Skilled
Ability to Problem Solve Independently & with Others - Highly Skilled
Business Organization & Industry Awareness - Highly Skilled
Cross Functional Relationships and communication skills - Highly Skilled
Execution / Results / Process Improvement - Highly Skilled
 
Background / Required and Preferred Education Level:
Bachelor of Science in Nursing or Bachelor of Science with Major in Nursing
RN Required