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Medical reviewer/safety reviewer iii

2 months ago

North Chicago, United States Randstad Full time

job summary:
As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you

location: North Chicago, Illinois
job type: Contract
salary: $45.00 - 54.97 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

  • 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 PPS 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.
  • 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 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.
qualifications:
  • RN Required
  • Proficient in Microsoft Office tools, Data Analysis, Research, Data Automation, Case processing of Device SAE/AEs, device complaints and SADE potential 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

skills: MS-EXCEL, GCP (Good Clinical Practice), SAE (Serious Adverse Event), ICH Regulations

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

This posting is open for thirty (30) days.