Medical Safety Associate - Belgium

Company Description

At SGS, you can choose!

First of all, out of our various vacancies.
However, SGS also gives you another choice.
Do you choose to expand or to enrich? We are not only looking for colleagues who can go in to depths of their discipline. We are equally as much looking for colleagues who we call ‘connectors’, people who can connect our diversity to our services. To each other. And this way, enrich our business.

SGS is the world’s leading inspection, verification, testing and certification company. We’re also the benchmark worldwide for quality and integrity. And that makes us very proud. This can only happen thanks to almost 100 000 colleagues worldwide, with more than 1650 employees in Belgium only. Our employees give 110% of themselves every day, divided over all expertises, branches and cultures. Our coworkers build their own way inside the company, the services and the expertise.

SGS Life Sciences carries out all type of services for pharmaceutical and biotechnology companies, from coordination and running of clinical trials with new molecules or techniques on human beings, to support and consultancy on post marketing registration activities.
SGS Life Sciences has also expertise in the quality control of pharmaceuticals.

In the spirit of continued growth and to help improve our business, we are currently seeking for a Medical Safety Associate (Mechelen).

Job Description

Serious Adverse Events/Adverse Drugs Reactions (SAEs/ADRs) handling (Clinical Trial and Post Marketing) including review of SAEs/ ADRs, performing regulatory assessments and contacts with reporters in order to have events fully documented
Submission of safety reports to Health Authorities and Ethics Committees as required per project agreements.
Maintain an overview the different Health Authority and Ethics Committee safety reporting requirements
Follow up on guidance documents and legislation related to Pharmacovigilance and share knowledge with the team
Involved as internal and external contact for pharmacovigilance projects
Setup of a project plan in agreement with the client requests and budget
Follow up on timelines and see to it that the different responsibilities and assignments are managed as agreed with the client

Qualifications

What do you need to be successful?

University degree in life sciences
Experience is a plus!
Quality minded; eye for detail and being able to make distinction between main and side issues
You speak and write fluently in English; any other languages (French and/or German) are a big plus
Very good knowledge of MS Office, Word etc
Respecting budgets and timelines
Being able to prioritise issues according to importance
On the practical side: you live in Belgium

Additional Information

What we have to offer:

Were you already considering a switch or new step in your career?

Maybe this could be the one!

At SGS you can count on an interesting position where you can take responsibility.

We work towards your professional growth and will support you during your career development path.
A good work-life balance.

Come enjoy our team of colleagues and take your chance to be part of a great and dedicated team!

Do you want to be part of this?

We are looking forward to hearing from you!

Send us your story and your resume via the apply button and maybe you will soon join us for work and coffee breaks.

Still have questions? Heidi Aerts can give you more details about the job.
Send her an e-mail at [email protected]