Medical Device, Complaint Handling, Adverse Event, Post Marketing, Rn

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 PSEQ 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:

• Medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings.
• May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies.
• Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical Adverse Events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on Adverse Events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and Client community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database.
• Off-label information would be disseminated at this level. May provide training internally and at investigator meetings on safety issues, responsible for serious Adverse Events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification

Activities performed under this team:

• 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 and proper product safety usage as needed.
• 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.

Qualifications:
Desired Skills:

• 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)
• 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

Core Essential Skills:

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

Education:

• Bachelor of Science
• Biomedical engineer or RN preferred

Job Types: Contract, Full-time

Pay: $47.00 per hour

Benefits:

• Health insurance

Schedule:

• 8 hour shift

Work Location: Remote