Medical Safety Associate - Mechelen, België - SGS

SGS

Geverifieerd bedrijf

Mechelen, België

2 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

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 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.

We are currently looking for a
Medical Safety Associate.

Job Description:

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
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
Creation of Safety Signal reports
Involved as internal and external contact for medical safety 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:

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
Fluently writing and speaking
English
Very good knowledge of Word
Respecting budgets and timelines
Being able to prioritise issues according to importance

Additional Information

What we have to offer:

Were you already considering a switch or next step in your career? Maybe this could be your next step.

At SGS you can count on an interesting position where you can take responsibility. Come enjoy our fun team of colleagues and on top of that, we will reward you with an interesting salary package (incl. retirement plan, meal vouchers,)

**Do you want to be part of this?