Excellent opportunity to join a leading pharma company as a Senior Manager - Global Quality Management.
The main task is to manage and perform audits with focus on Pharmacovigilance audits. Additional tasks are to support the continuous improvement of Quality System, the inspection management, the regulatory intelligence activities, the SOP and WP management, the validation activities and the project liaison activities.
Key Responsibilities
- Pharmacovigilance Audits
- Quality Systems
- Regulatory Inspections
- Regulator Intelligence
Qualifications / Experience
- Leading, co-auditing and supporting Pharmacovigilance Audits within an independent Quality Department
- Internal pharmacovigilance processes
- Clinical / industry / Regulatory Authority or otherwise relevant experience, preferably including Quality Management for Pharmacovigilance
- Prior relevant experience of working in pharmacovigilance
- Expert knowledge / experience in relevant pharmacovigilance regulations and guidance documents
- Exposure to regulatory inspections
- Must be able to travel globally to perform audits and to support regulatory inspections and mock inspections
