Medical Reviewer
TR/077809
Posted: 28/05/2025
- $35 - $38 per hour
- United States, Remote work
- Contract
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:
Experience & Skills:
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
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
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Colin Murray-Bain
US Life Sciences
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