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Medical Reviewer

3 months ago

South San Francisco, United States US Tech Solutions Full time

Duration: 12 months contract


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.


Responsibilities:

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

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


Experience:

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)


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


Education:

Bachelor of Science in Nursing or Bachelor of Science with Major in Nursing

RN Required


About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit


US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.


Recruiter Details:

Name: Deepak

Email: deepakm@ustechsolutionsinc.com

Internal Id: 24-18136