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| Firma: |
Kelly services (Suisse) SA |
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| Job-Titel: |
Manager, Pharmacovigilance and Clinical Quality Assurance |
| Job Kategorie: |
Sachbearbeit/Qualitätskontrolle |
| Arbeitsort: |
der Schweiz |
| Stellen-Beschreibung: |
-Plans and conducts global PVCQA audits.
Communicates audit findings, evaluates and follows up on the appropriateness and completeness of corrective action plans until closure. PVCQA audits can include:
Clinical investigator sites
Clinical and/or pharmacovigilance systems and/or processes
Regulatory submission related documents
Third party vendors, e.g., CROs, central laboratories, phase I facilities, etc.
• Country affiliate organizations and central sites
- Supports clinical and/or pharmacovigilance teams and projects or initiatives
- Actively participate in the SOP and regulatory submission document reviews and approval processes.
- Support, manage, lead and/or host regulatory inspectional activities globally including pre, during and post inspections.
- Develops and/or provides GCP and PV QA/compliance/quality related training/education to the or-ganization or during clinical investigators` meetings as needed.
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| Kenntnisse erforderlich: |
8+ years of pharmaceutical industry experience in quality assurance, pharmacovigilance, clinical research and drug development, regulatory affairs or regulatory compliance, with 3+ years GCP/PV auditing/compliance experience
Working knowledge of applicable PV and/or GCP regulations and guidelines
Travel worldwide approximately 20-30%
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Sprachkenntnisse: |
Englisch-Sehr GutFranzösisch-Gut |
| Beschäftigungsart: |
Vollzeit |
| Jahresgehalt: |
Keine Angabe |
| Eintragsdatum: |
2009-10-09 |
| Grad der Ausbildung: |
Master |
| Ihre Erfahrung in Jahren: |
7 to 10 Years |
| Firma: |
Kelly services (Suisse) SA |
| Kontakt-Name: |
Kelly Scientific Resources |
| Kontakt-Telefon: |
0041 22 737 12 06 |
| Kontakt -Fax: |
0041 22 737 12 13 |
| Bevorzugte Kontaktmethode: |
E-mail |
| Preferred Language of Resume/Application: |
French |
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