Post Market GU Case Reviewer
Publication date:
25 September 2024Workload:
100%Contract type:
Permanent position- Place of work:Johnson
Johnson & Johnson is currently seeking a Post Market GU Case Reviewer to join our Abiomed team located in Danvers, MA.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
Summary and Scope:
This role is part of Abiomed’s Post Market Surveillance program. The Post Market GU Case Reviewer is responsible for reviewing General Use (GU) cases (patient/surgical procedure case notes) to identify product complaints and adverse events in compliance with global medical device regulations. This individual will be tasked with assisting in the creation/maintenance of documentation to ensure the case review process is consistently implemented and continually improved. Lastly, they will provide insight to the post market engineering leadership team regarding inconsistencies they note so that closed loop feedback can be provided to the field/CSC/intake teams.
Key Responsibilities:
- Review all General Use cases and determine if they represent a complaint or adverse event.
- If a complaint or adverse event is noted, escalate the case to the Post Market Engineering team for processing in accordance with Standard Operating Procedures.
- Create documentation to ensure the case review process is thorough and consistent.
- Recognize when issues or trends occur and escalate to management as the situations arise.
- Note intake inconsistencies so that constructive feedback can be given to appropriate teams driving continuous improvement.
There is an internal pre-identified candidate for consideration. However, all applications will still be reviewed.