BrightOwl Loader Loading

Quality Manager / Drug Safety Manager (60%) - Switzerland  

Takeda (company)

Posted on : 19 September 2017

Project Description

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