Medical Safety Associate - Belgium in Mechelen

Beschrijving

• 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

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

Extra informatie

Status

Open

Opleidingsniveaus

HBO5

Plaats

Mechelen

Dienstverbanden

Fulltime (startersfunctie)

Gepubliceerd op

03-03-2025

Beroepsgroepen subcategorie

Administratief

Rijbewijs nodig?

Nee

Auto nodig?

Nee

Motivatiebrief verplicht?

Nee

Talen

Arabisch