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| Company: |
Kelly services (Suisse) SA |
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| Job Title: |
Manager, Pharmacovigilance and Clinical Quality Assurance |
| Job category: |
Quality Control |
| Job Location: |
Switzerland |
| Job Description: |
-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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Skills Required:: |
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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Language Requirements: |
English-Very GoodFrench-Good |
| Employment Type: |
Full Time |
| Yearly Salary: |
Unspecified |
| Posting Date: |
2009-10-09 |
| Level of Education: |
Masters |
| Years of Work Experience: |
7 to 10 Years |
| Company: |
Kelly services (Suisse) SA |
| Contact Name: |
Kelly Scientific Resources |
| Contact Phone: |
0041 22 737 12 06 |
| Contact Fax: |
0041 22 737 12 13 |
| Preferred Method of Contact: |
E-mail |
| Preferred Language of Resume/Application: |
French |
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