Job Description

Job Description

Job Description

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 PSQ 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.

Responsibilities:

• Responsibilities include medical review and assessments, which involve in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings.
• May collaborate with regional contract CRAs, and organize the files associated with several clinical studies.
• Provides medical support which may include Adverse Event Reporting - the investigation and reporting of medical devices products, in depth investigation of medical device adverse events and collaboration with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on medical device adverse events for the health authorities.
• May provide training internally on safety issues, responsible for serious adverse events processing and reporting.
• 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.
• Gain understanding of risk management regulations, standards, and guidance for medical devices and combination products.

Requirements:

• Bachelor of Science in Nursing or Bachelor of Science with Major in Nursing.
• RN Required (Active licensure).
• CRO experience.
• Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation, Case processing of Device SAE/AEs, device complaints, SADE potential and IVD 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.
• Ability to Meet Challenging Milestones with results orientation.
• Strategic Decision Making and Negotiation.
• Facilitating Change and managing conflicts.
• Ability to Problem Solve Independently & with Others.
• Business Organization & Industry Awareness.
• Cross Functional Relationships and communication skills.
• Execution / Results / Process Improvement.

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