Beschreibung
For my client, a global pharmaceutical company based near Frankfurt, I am currently looking for a "Freelance Audit and Inspection Coordination Support" to support the Global Drug Safety Department. The project starts in March with a capacity of 5 days/week on-site and a project length of approx. 3 months.You will be responsible for the following tasks:
- Preparation of inspections involving global and affiliate drug safety processes
- Leading inspection preparation across worldwide Drug Safety functions and ensuring that functions outside Drug safety are appropriately involved
- Leading and coordination all pharmacovigilance-related activities in inspections and audits
- Ensuring quality of all pharmacovigilance-related documentation
- Support to Drug Safety affiliate staff before, during and after inspections/audits
- Contributing to the maintenance of a CAPA database for GDS oversight of PV related CAPA plans
- CAPA Plan Management
For this role, the following qualification is required:
- Extensive experience in pharmacovigilance
- 5+ years GVP experience
- 5+ years Operational Inspection and Audit experience
- 3-5 years active participation in managing inspections
- Very good understanding of current worldwide pharmacovigilance legislation
- English business fluent
If you have the experience and if you are interested in this opportunity, please contact Johanna Klonek at Real Staffing on or email
I am looking forward to your application!
Mehr Informationen über Real Staffing erhalten Sie unter www.realstaffing.de