Medical / Safety Reviewer III - REMOTE

Proclinical is seeking a remote Medical / Safety Reviewer with a leading biopharmaceutical company. 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.

Job Responsibility:

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

Skills and Requirements:

• Bachelor of Science
• Biomedical engineer or RN preferred
• Medical Device Risk Management experience preferred
• Medical Device complaint handling experience preferred
• Medical Device literature searches/reviews experience preferred
• Knowledge of electronic databases (e.g., TrackWise, Business Objects, Oracle, Argus, 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
• Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation 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)
• Ability to Problem Solve Independently & with Others - Highly Skilled Execution / Results / Process Improvement - Highly Skilled Cross Functional Relationships and communication skills - Highly Skilled

If you are having difficulty in applying or if you have any questions, please contact Kelly Campbell at (+1) 570-277-7115 or k.campbell@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-KC4