Vigilance Specialist M/F
Aixial
- Brussel
- Vast
- Voltijds
- 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 applicable
- 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
- 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
- Fluent in English (spoken and written) is mandatory
- We are one of the world's leaders in CRO (Contract Research Organisation) with the commitment, expertise, and flexibility needed to deliver efficient clinical trials.
- We work with global pharmaceutical, biotech, cosmetic, medical device, and many other companies around the globe, providing them with innovative and scalable solutions.
- We are operating in 10 countries across 3 continents, bringing together over 1000 talented professionals dedicated to make a positive impact in the life sciences industry.
- We have been part of ALTEN Group since 2014 and are continuously exploring new opportunities to expand our activity worldwide.
- Make a positive impact and be at the forefront of project:
- Career Development:
- Our commitment to Diversity, Equality, and Inclusion: