Quality Manager/Drug Safety Manager


Zurich, Switzerland

Role Objective

  • Support Qualified Person in all aspects of Quality and Pharmacovigilance in accordance to Swiss regulations;
  • Cooperation with different local and global functions;
  • Reporting into LOC Quality Head/Drug Safety Officer.


Area Quality

  • Ensures Global Distribution Practice/Global Manufacturing Practice compliance in cross functional collaboration with Regulatory Affairs and Supply Chain;
  • Performs local national release in accordance to Swiss requirements;
  • Manages local deviations;
  • Manages complaints with the manufacturing site and the global functions;
  • Manages change requests in accordance with quality agreements;
  • Qualification of customers and suppliers;
  • Support Qualified Person in self-inspections, audits and authority inspections;
  • Adaption and review of local SOPs;
  • Support Qualified Person for mandatory trainings.

Area Drug Safety

  • Manages safety information in Takeda local Pharma Covigilance unit (LOC) according to appropriate Standards and SOPs;
  • Monitors local Risk Management Plans (RMP) and risk minimization activities;
  • Support Market Research (MR) and/or Patient Support Programs (PSPs) as local PV partner;
  • Review local medical literature;
  • Support PV audit/ inspection readiness at the LOC and as appropriate in PV audits and inspections.

Key Capabilities:

  • Pharmacist, or master in science;
  • Minimum 3 years of experience in pharmaceutical industry in Quality, Pharmacovigilance or Regulatory Affairs;
  • Identification with Takeda-ism values;
  • Fluent written & spoken German & English/fluent spoken French.

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