The Life Science Career Network

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a:

PVQA (Pharmacovigilance and Quality Assurance) Manager      

for a 12 months-contract based in the area of Basel.

Main Responsibilities:

  • Providing expertise and supporting Pharmacovigilance unit;
  • Representing PVQA for Pharmacovigilance System;
  • Supporting the company, the suppliers and vendor teams (e.g. GDS, GMA, Marketing, affiliate) in staying compliant with regulatory requirements (e.g. answering questions; participating to meeting to discuss PV issues);
  • Qualifying PV vendors;
  • Completing PSMF part under responsibility of PVQA;
  • Escalating serious or continuing non-compliance PV issues as appropriate/necessary;
  • Providing support with trainings on PV requirements;
  • Contributing to PV process improvements (e.g. via audit finding / CAPA) and PV electronic systems (e.g. Testing Quality Event Module);
  • Managing PV deviation as per Deviation QS documents;
  • Facilitating the PV inspections and CAPAs elaboration, approval and follow-up PVQA Audit;
  • Planning, performing, and reporting standards GVP audits (e.g. affiliate, supplier, process, studies).

Qualifications and Experience:

  • Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
  • At least a bachelor degree or equivalent education/degree in sciences or healthcare;
  • At least 3 years of experience within pharmaceutical industry/health authorities working in Pharmacovigilance field;
  • Good knowledge of GVP regulatory requirements and pharmaceutical industry practices;
  • Experience in GxP quality systems, compliance monitoring, CAPA management, and/or the development and maintenance of standards and training programs;
  • Being an Auditor.

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us.