Quality Manager/Drug Safety Manager
- 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.
- 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.
- 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.
Don't forget to mention EuroPharmaJobs when applying.