Medical Reviewer

Orion Group; Chicago (IL); Remote; Full time

Job summary

A leading company is seeking a Medical Device Safety team member. This remote role involves ensuring patient safety through effective collaboration on high-priority analytical strategies and clinical oversight projects. Candidates must be RNs and proficient in data analysis, clinical trials, and regulatory guidelines.

Qualifications

• Candidates MUST be a RN to be considered for this role.
• Knowledge of R&D regulatory guidelines is required.
• Clinical Trial Device Experience preferred.

Responsibilities

• Assisting with ongoing continuous improvement projects.
• Responsible for medical device safety reporting.
• Provide support for training and automation efforts.

Skills

Data Analysis

Research

Data Automation

Case processing of Device SAE/AEs

Clinical Trial Experience

Ability to multi-task

Attention to detail

Education

Registered Nurse (RN)

Tools

Microsoft Office

Rave EDC

Veeva EDC

Salesforce

Job description

Location: Remote (US)

Contract Length: 12 Months

Pay Rate: $35-38/hr

Candidates MUST be a RN to be considered for this role

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 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.

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., 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
• Ability to multi-task and prioritize while maintaining attention to detail with high quality outputs