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 applicable
  Business 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

Who Are we?

• 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.

Why Join Us?

• Make a positive impact and be at the forefront of project: 

You will be part of groundbreaking advancement in clinical research that has positive impacts on millions of people’s lives globally.

• Career Development:

People are our biggest asset. We are committed to empower our team continually and build a positive and supportive environment that fosters growth, flexibility, and teamwork. At Aixial Group, you will be coached and mentored throughout your journey to help you advance your professional and personal growth.

• Our commitment to Diversity, Equality, and Inclusion:

We aim to create a workforce which promotes dignity and respect, where individual differences are recognized and valued, and where each employee can give their best.

Gender equality is at the core of the development strategy of Aixial Group.

Aixial Group continues to grow, and to recruit in the clinical trial professions. Join us, and discover our website to follow the news of our offers: https://www.aixialgroup.com/join-us/

For more information: https://www.linkedin.com/company/aixialgroup/about/