Vigilance Specialist M/F

at  Aixial

You are a highly skilled professional with passion for the world of Life Sciences and Clinical Research? You want to thrive in a dynamic and collaborative international environment where your expertise directly impacts people lives?
Come and join Aixial Group to contribute to shaping the future of clinical research!
Aixial Group is currently hiring a Vigilance Specialist for a position based in Brussels.
As a Vigilance Specialist, you will be responsible to review and process product complaints received through various communication modalities and contribute to complaint management system in accordance with internal and external complaint handling procedures while demonstrating world-class customer support

Your tasks will be to (non-exhaustive list):

• Demonstrate world class customer support
• Possesses understanding of complaint management for the review of complaint files within scope of internally and externally manufactured products in accordance with associates complaint handling procedures and Customer Quality expectations.
• Utilize MD Workflow reports to identify tasks and manage common email inboxes
• Make regulatory reporting determinations on applicable files for the applicableBusiness Unit
• Appropriately utilize risk management documentation to support the complaint’s regulatory reporting process
• Manage Health Authority Requests of Health Authorities including justifications for non-reporting in accordance with EU regulations as applicable
• Participate in audit and compliance review processes as needed
• Support Clinical Department for Adverse Event reconciliation
• Ensures the regulatory reporting of serious adverse events from pre-market studies are completed and reported according to regulatory requirements.
• Responsible for communicating business related issues or opportunities to next management level

Professional experiences, qualifications and skills required :

• BS degree in science would be required
• At least 3 years of work experience within a regulated medical device/clinical environment
• Good computer and communication skills

Languages :

• Fluent in English (spoken and written) is mandatory

• Demonstrate world class customer support
• Possesses understanding of complaint management for the review of complaint files within scope of internally and externally manufactured products in accordance with associates complaint handling procedures and Customer Quality expectations.
• Utilize MD Workflow reports to identify tasks and manage common email inboxes
• Make regulatory reporting determinations on applicable files for the applicableBusiness Unit
• Appropriately utilize risk management documentation to support the complaint’s regulatory reporting process
• Manage Health Authority Requests of Health Authorities including justifications for non-reporting in accordance with EU regulations as applicable
• Participate in audit and compliance review processes as needed
• Support Clinical Department for Adverse Event reconciliation
• Ensures the regulatory reporting of serious adverse events from pre-market studies are completed and reported according to regulatory requirements.
• Responsible for communicating business related issues or opportunities to next management leve