Medical Reviewer Jobs

Location: Fully Remote (US)

Contract Length: 12 Months

Pay Rate: $50/hr including individual healthcare coverage

The Pharmacovigilance and Patient Safety (PPS) organization works collaboratively and strategically with colleagues across the product lifecycle to identify, evaluate, understand, and communicate the safety profile of company products to protect patients worldwide.

Within the PPS Organization, 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 PPS 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.

Activities performed under this team:

• Assisting with ongoing continuous improvement projects spanning across departmental needs
• Support medical safety consultation activities in matters related to risk/benefit and proper product
• Providing support for training and automation efforts
• Safety usage as needed.
• Participate in root-cause investigations into device failures and human factors-related use errors.
• Gain understanding of risk management regulations, standards, and guidance for medical devices
• Identify regional label variances and build tool to capture info for priority products and main
• Competitors
• And combination products.

Qualifications

• Biomedical Engineer or RN highly preferred
• Bachelor of Science

Desired Skills:

• Knowledge of Research & Development and an understanding of regulatory guidelines /
• Ability to effectively interact with and influence others without direct reporting relationships
• Safety reporting)
• Requirements related to R&D Medical Devices/Combination Products (e.g., ICH, GCP, CFR, EU-MDR,
• Ability to multi-task and prioritize while maintaining attention to detail with high quality outputs
• Knowledge of electronic databases (e.g., TrackWise, Business Objects, Oracle, Argus, other database
• Tools)
• Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation

Core Essential Skills:

• Cross Functional Relationships and communication skills - Highly Skilled
• Strategic Decision Making and Negotiation - Skilled
• Business Organization & Industry Awareness - Highly Skilled
• Ability to Meet Challenging Milestones with results orientation - Skilled
• Facilitating Change and managing conflicts - Skilled
• Ability to Problem Solve Independently & with Others - Highly Skilled
• Execution / Results / Process Improvement - Highly Skilled

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.