Belgique 05.03.2021

Pharmacovigilance Quality Improvement Partner

Tasks

AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Switzerland, Belgium, Germany and Czech Republic.

We are currently looking for a Pharmacovigilance Quality Improvement Partner to drive the improvement of the Pharmacovigilance Quality System through the Global Pharmacovigilance Audit Lifecycle, including:

  • Audit preparation activities including review and finalization of the audit agenda, coordination with subject matter experts, logistics and collection of documents
  • Hosting of PV audits
  • Driving root cause analysis and CAPA development with Observation Owners
  • Overseeing and Coordinating CAPA delivery with CAPA owners
  • Participating in Pharmacovigilance Quality Governance meetings
  • Bridge builder between Auditor and Auditee
  • Ensuring overall quality and timeliness of Root Cause Analysis and CAPA agreement as well as on time delivery of PV Audit CAPA and their associated evidences

Requirements

  • BSc. degree 
  • At least 3-5 years’ experience in the pharmaceutical/biotechnology area including time working in Pharmacovigilance Quality-related areas
  • Fluent in English
  • Experience with Veeva Systems, Qliksense, and/or Sparta’s TrackWise is a plus
  • Good understanding of Quality, knowledge of GPvP and applicable regulatory framework 
  • Strong managerial and organisation skills
  • Ability to lead medium projects
Apply
SPONTANEOUS APPLICATION
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SPONTANEOUS APPLICATION








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