Quality Assurance and Compliance Specialist

3 days ago

Toronto, Canada University Health Network Full time

Job Posting #903252
Position: Quality Assurance and Compliance Specialist (Vanessa's Law, Alerts and Recalls)
Site: Toronto General Hospital
Department: Medical Engineering
Hours: 37.5 Hours/WeekSalary: $79,622 to $99,528
Status: Temporary Full-time (Contract)

University Health Network (UHN) is looking for an experienced professional to fill the key role of Quality Assurance and Compliance Specialist in our Biomedical Engineering Department.
- The Energy of the City. The Rewards of a Great Career._

The University Health Network, where “above all else the needs of patients come first”, encompasses Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute and the Michener Institute of Education. The breadth of research, the complexity of the cases treated, and the magnitude of its educational enterprise has made UHN a national and international resource for patient care, research and education. With a long tradition of ground-breaking firsts and a purpose of “Transforming lives and communities through excellence in care, discovery and learning”, the University Health Network (UHN), Canada’s largest research teaching hospital, brings together over 16,000 employees, more than 1,200 physicians, 8,000+ students, and many volunteers. UHN is a caring, creative place where amazing people are amazing the world. Find out about our purpose, values and principles here.To transform lives, we take bold steps. This means continuously elevating our ambitions and not settling for less when it comes to improving the lives of others and all those on TeamUHN. We know the road to excellence is not covered by a single plan, but a shared commitment to the betterment of all. UHN’s 2019-23 Strategic Plan is built on that shared commitment and serves as our guide for harnessing our efforts across care, research and education. This plan will help us make important choices and presents our way to a better future —? A Healthier World for all.When people come to UHN, they can and should expect the highest quality in the domains below - and it’s our privilege to deliver on them. UHN’s Essentials — Compassionate Care and Caring, Environments, Operational Excellence, Partnerships, People and Culture, Quality and Safety, and Technology — represent our central responsibilities as a leading academic health sciences centre. UHN’s Strategic Priorities build on our Essentials and help us create A Healthier World.Job Summary:The Quality Assurance and Compliance Specialist will be an ambassador for quality assurance and compliance with applicable standards, primarily as it relates to the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) and will be the pivotal Lead for the following accountabilities:

- Support UHN in the mandatory reporting to Health Canada of serious adverse drug reactions (ADRs) and medical device incidents (MDIs) that involve a therapeutic product, in order to comply with regulations, put in place through the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law). This involves: reviewing reported patient safety events and engaging other team members as well as interprofessional teams across UHN to identify ADRs and MDIs that meet the criteria for submission, collecting necessary information for ADR and MDI reports to Health Canada, submitting ADR and MDI reports to Health Canada, maintaining documentation related to the review and submission of ADR and MDI reports, and providing data and information in response to ad hoc information requests from internal stakeholders.
- Manage UHN’s response to alerts and recalls issued by federal agencies, manufacturers, suppliers, and other groups for medical devices (equipment), consumable/disposable products, implanted devices, etc. This involves: overseeing UHN’s centralized alert management software system, communicating and coordinating with interprofessional teams responsible for evaluating and acting on alerts, ensuring effective alert processing, and providing data and information in response to ad hoc information requests from internal stakeholders.
- Ensure that the processes needed for compliance with these requirements are established and provide oversight for the implementation and maintenance of these processes. This includes required policies, procedures, communication strategies for both internal and external stakeholders (including patients, if applicable) and, guidelines for risk assessment involved in the review of the notifications received.
- Establish the required governance framework including an Alert/Recall Committee with key internal stakeholders (e.g. UHN Legal, Chief of Surgery, Chief of Medicine, Cardiac Medical Director, Medical Engineering, Pharmacy and others as applicable) to provide institutional guidance on decisions that have institutional impact including notifications to patients or where the risk assessment identifies a moderate or high risk ADR o

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