Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients.
We are committed to putting essential medicines and technologies in the hands of people who help patients and finding the best answers to the challenges they face. We are dedicated to a higher purpose "caring for life" which drives excellence in everything we do.
Fresenius Kabi has a long history in clinical nutrition and is one of the world’s leading suppliers of lipid emulsions for parenteral nutrition with an exciting new portfolio.
We are currently seeking a full-time Sr. Associate, Vigilance, Medical Device to join our team, at our corporate office in Toronto (165 Galaxy Blvd.).
- The Sr. Associate Vigilance, Medical Device will review and process domestic and international complaints for Medical Device Reporting (MDR) based on Health Canada Regulations and International [Medical Device Directive (MDD)] Device Reporting requirements.
- Will establish an effective and timely system for conducting problem report investigations that complies with the Canadian Medical Devices Regulations.
NATURE & SCOPE
The Sr. Associate Vigilance, Medical Device will be responsible for the evaluation, reporting, record keeping and quality control in accordance to Health Canada Guidance Document for Mandatory Problem Reporting for Medical Devices.
Responsibilities include, but are not limited to:
- Review incoming domestic and international complaints on a daily basis to determine reportability based on Health Canada Medical Devices Regulations (MDR) and requirements.
- Assist in generating sound rationales for non-reportable events based on regulatory knowledge and/or clinical experience.
- Contact the customer/user and/or other resources to gather patient/incident information to aid in reportability decision.
- Document MDR, Vigilance, Foreign Adverse Event Reporting decisions under the supervision of the Manager.
- Highlight any potential reportable medical incidents to QA and/or RA Management as soon as possible as per the Medical Device Reporting/Vigilance procedures.
- Complete, prepare and submit MDR reports within the timeframes specified by Regulations.
- Process all reportable medical incidents to closure per domestic and international regulations and internal procedures.
- Assist QA in preparation of complaint written replies/letters to the customers and international affiliate/distributor as requested
- Review Evaluation Result reports to prepare and complete Preliminary Investigations to ensure complaints are processed and closed within the required timeframe.
- Participate in corrective/preventive action and product design team meetings as required.
- Assist in Health Hazard Analysis by contributing and reviewing Risk Assessments, as per local requirements.
- Ensures the information library reflects current understanding and is maintained in a timely and comprehensive manner. This includes an abridged library of relevant material accessible to field representatives.
- Communicates with the Fresenius Kabi Regional and Global Medical Device Safety and Quality department to ensure information provided is up-to-date and accurate.
- Maintain high compliance standards with respect to reporting timelines and quality of local ADR data, medical devices mandatory problem reporting, as well as, with respect to responding to inquiries received from internal/external customers, by ensuring all standard operating documents are followed and that the department is inspection/audit ready at all times.
- Assist the Manager Vigilance with safety data processing, evaluation, reporting, record keeping and quality control in accordance to Health Canada pharmacovigilance/medical device mandatory problem reporting guidelines and corporate requirements.
- Initiation and conduct of follow-up activities related to local ADRs reports including direct telephone follow-up as required.
- Keep up-to-date regarding Canadian and international regulatory developments in the Pharmacovigilance / Medical Device area
- Provide input in the creation and maintenance of local SOPs to ensure compliance with domestic regulations and corporate guidelines related to the reporting of Adverse Reactions as well as mandatory problem reporting for medical devices.
- Collaborate with local and global cross-functional teams as required.
- Provide support to Manager Vigilance in internal and external audits and inspections.
- Perform any other duties as assigned
- Degree in Health Sciences, Pharmacy, Biomedical Sciences, etc,.
- Experience of a minimum 3 years in the medical device / pharmaceutical / industry is required (Pharmacovigilance/Medical Device including experience in handling medical device complaints and adverse events.)
- Superior time management skills, and ability to work independently or in team
- Knowledge of relevant Health Canada regulationsVigilance Medical Devices and pharmaceuticals.
- Awareness of Good Documentation practices applicable to Medical Device regulatory requirements.
- Strong verbal and scientific writing skills
- Written or spoken French is an asset
- Ability to manage simultaneous projects
- Advanced level skills using Microsoft Office products such as Word, Excel, Adobe and Power Point
- Able to work in a multi-cultural environment
- Very strong attention to detail
If you are interested and qualified, we invite you to send your resume.
** PLEASE INCLUDE THE JOB TITLE IN THE SUBJECT LINE WHEN APPLYING – Sr. Associate, Medical Device