Medical/Safety Reviewer - Remote

Description:

• Providing support for training and automation efforts
• Identify regional label variances and build tool to capture info for priority products and main competitors
• Gain understanding of risk management regulations, standards, and guidance for medical devices and combination products.
• 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.
• The team is a high-profile high-impact team that works with PPS functions on a range of product initiatives.
• Assisting with ongoing continuous improvement projects spanning across departmental needs
• 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.
• Participate in root cause investigations into device failures and human factors related use errors.
• The Pharmacovigilance and Patient Safety (PPS) organization works collaboratively and strategically with colleagues across the product life cycle to identify, evaluate, understand, and communicate the safety profile of products to protect patients worldwide.
• Support medical safety consultation activities in matters related to risk/benefit and proper product safety usage as needed.

Qualifications:

• Ability to Meet Challenging Milestones with results orientation – Skilled
• Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation
• Business Organization and Industry Awareness - Highly Skilled
• Ability to effectively interact with and influence others without direct reporting relationships
• Knowledge of electronic databases (e.g., TrackWise, Business Objects, Oracle, Argus, other database tools)
• Facilitating Change and managing conflicts – Skilled
• Execution / Results / Process Improvement - Highly Skilled
• Strategic Decision Making and Negotiation – Skilled
• Ability to Problem Solve Independently and with Others - Highly Skilled
• Knowledge of Research and 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)
• Bachelor of Science
• Ability to multi-task and prioritize while maintaining attention to detail with high quality outputs
• Cross Functional Relationships and communication skills - Highly Skilled
• Biomedical engineer or RN preferred