TOP SKILLS

• result driven
• Critical thinker
• Multitasker

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 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.

EXPERIENCE & SKILLS:

• 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 – 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
• Background / Required and Preferred Education Level
• Bachelor of Science in Nursing or Bachelor of Science with Major in Nursing
• RN Required (Active licensure)
  Job Type: Contract
  Pay: $43.00 - $44.00 per hour
  Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Medical Specialty:

• Cardiology
• Critical & Intensive Care
• Emergency Medicine
• Home Health
• Medical-Surgical
• Surgery
• Telemetry

Physical Setting:

• Acute care
• Inpatient
• Nursing home
• Outpatient
• Rehabilitation center

Experience:

• dical Device Complaint handling: 3 years (Preferred)
• Medical Device industry: 3 years (Preferred)
• Medical device case processing: 3 years (Preferred)
• clinical trials: 3 years (Preferred)

License/Certification:

• RN License (Preferred)

Work Location: Remot