On behalf of our client, a global pharmaceutical company, we are hiring an QA and Pharmacovigilance Specialist with good knowledge in Clinical Studies ( Phase I through Phase IV).
This position is currently fix-termed from February until end of October 2020 with possible extension.
QA and Pharmacovigilance Specialist
Major activities :
Responsible for Good Clinical Practice and Good Pharmacovigilance Practice oversight and for assuring quality and compliance of Development and Medical Affairs projects, products and programs as well as GxP activities related to Marketing
Provide guidance for the preparation, conduct and follow-up of GCP and Pharmacovigilance related audits
Ensure that responses to local health authorities have been submitted, commitments have been met and relevant actions plans have been completed
Management of vendors in the GCP / PV area as well as for Patient Oriented Programs
Perform the release of Investigational Medicinal Products for clinical trials, investigator-initiated trials and managed access programs
Support the implementation of global SOPs to local Quality Management System
Degree in Life Sciences or related fields
English fluent in speaking and writing, other languages are an asset
Min. 3 years’ experience in the pharmaceutical industry in a rele vant field such as quality assurance, pharmacovigilance, clinical development or a directly related area
Strong project management skills