Safety Database Admin

vor 2 Monaten


Fribourg, Schweiz Manpower Vollzeit

Do you want to join Philip Morris? We're looking for a:
**Your mission**
Duration : open-ended contract through Manpower

Remote work : 3 days per week

Location : Neuchâtel

**Your profile**
- Primary point of contact for detected issues in the Safety Database
- Assessment and resolution of the encountered issues, raising issues to the vendor if needed
- Following up on the issues with the vendor until resolution
- Define the business requirements with the Case Management team and implement them in the Safety Database following the Change management process
- Detect system performance issues and implement solutions to resolve them
- Create templates for various aggregate reports (e.g. Signal Detection) and generate them on an adhoc basis
- Implement new systems or technical solutions in the Safety team in collaboration with IT, Validation team and other stakeholders
- Support in updating the QMS documents
- Support during audits and inspections
- Graduated with a BSc or MSc in Life Sciences or IT
- 1 or 2 years of experience in Pharmacovigilance activities with good knowledge of GVP guidelines OR
- 1 or 2 years of experience in the Safety Database maintenance (or other GxP systems)
- Able to understand the business need and “translate” it to system configuration
- Able to distinguish criticality of the Safety Database issues and prioritize them appropriately
- Strong verbal and written communication and documentation skills required with high attention to detail
- Willing and able to work independently in a dynamic corporate organization under pressure of tight deadlines and high expectations
- Proactive
- Analytical mindset
- Tech savvy

Advantages (but not requirements)
- Experience with Computerized System Validation (CSV) processes
- Experience with writing and running UATs or PQ test scripts
- Experience with vendor management
- Experience with compliance monitoring

**Interested?**
Don't hesitate to apply



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