Medical Reviewer/Safety Reviewer III Job at Planet Group, Illinois

UzU2SHlkcCs0ajdsdkFYR2w5WWdoNzhwS2c9PQ==
  • Planet Group
  • Illinois

Job Description

Pay range: 34-44/hr
*depending on experience

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 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.

Activities performed under this team:
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.
Biomedical engineer or RN Required

Experience & Skills:
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
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 Tags

Remote job, Contract work,

Similar Jobs

Gingie

Executive Sous Chef Job at Gingie

 ...Boka Restaurant Group , a James Beard Awardwinning hospitality group, and Chef Brian Lockwood are seeking an experienced and dynamic Executive Sous Chef to lead the opening team at Gingie , opening soon in Chicagos River North neighborhood. ~ Benefits... 

Alaska X

Alaska Boat Captain ($1,000 Signing Bonus!) - Skagway, AK Job at Alaska X

 ...guests by conducting a pre-trip inspection daily, driving at a safe rate of speed at all times, assisting guests into and out of the boat, reviewing safety guidelines with the guests, and ensuring children stay with their parents at all times Responsible for... 

Hwy Express

CDL Class A Driver Job at Hwy Express

 ...Are you an experienced Flatbed CDL A Truck Driver seeking a rewarding career with a company that values your hard work and dedication? Look no further than HWY Express. We're a leading provider of flatbed transportation services, committed to offering our drivers a competitive... 

Cactus Feeders Co.

Pen Rider - Burlington Feeders Job at Cactus Feeders Co.

 ...cattle annually. The Company has locations throughout the Texas Panhandle, Southwest Kansas, and Eastern Colorado. Location Burlington, Colorado Cactus Feeders is currently managing two growyards in the Burlington area, located approximately 6 miles apart.... 

Filmless

Freelance Animator & GFX Artist Job at Filmless

 ...before applying so that you know what kind of videos we create: Job Description Were looking for the best animators & GFX artists to help us create custom graphics/animations for our clients videos. You are a self-motivated person, with an eye for quality and...