8 - 40 uur per week
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
- Inactief
- Opleidingsniveaus
- Master
- Plaats
- Mechelen
- Werkuren per week
- 8 - 40
- Dienstverbanden
- Tijdelijke fulltime baan
- Beroepsgroepen subcategorie
- Onderwijs en Wetenschap
- Rijbewijs nodig?
- Nee
- Auto nodig?
- Nee
- Motivatiebrief verplicht?
- Nee
- Talen
- Nederlands
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