ICF Check Specialist (m/f), Bruxelles

AIXIAL is a company of ALTEN GROUP, the European leader in engineering. AIXIAL is a Contract Research Organization (CRO) providing services to the life science industry for 10 years. Our mission is to support the key players of the pharmaceutical industry in France and Europe on different types of services: Insourcing (CRO) and Outsourcing in environments as diverse as Biometrics, Clinical Research, Pharmacovigilance and Quality Assurance

Missions

• ensure that the use of human biological are in line with the patient consent,
• Consult the local ICF available,
• Analyze and interpret the wording of the local ICF regarding the purpose of the request,
• Give a positive or negative answer to the requester,
• Lead the HBSM Day-to-day meeting (composed by the HBSM Risk Coordinator, a second member of the HBSM Board and the ICF Check Team), the objective of this meeting is to address and discuss the request for which neither the ICF Check Team nor the responsible of the activity cannot endorse a decision,
• Handle issue linked to this processes, regulatory wise, etc

Profile

• pharmaceutique At least 2 years' experience in a pharmaceutical company in a clinical and laboratory environment Practical knowledge in a discipline linked to vaccines research and development. (immunology, physico-biochemistry, cell biology, molecular biology or pharmacology)
• Français Très bonne connaissance
• Anglais Très bonne connaissance
• Allemand Connaissance moyenne
• Permis de conduire :
  
• Permis de conduire
• Bonnes pratiques de laboratoire (BPL/GLP)
• experience in a clinical and laboratory environment
• immunology, cell-biology, molecular biology, pharmacology