Senior GVP Audit Manager
An exciting opportunity has arisen for a Senior GVP Audit Manager, you will be expected to oversee the pharmacovigilance audit activities and associated quality system elements to ensure the global PV audit program is maintained and executed to meet all legislative and internal requirements. This role is based in the UK.
- Responsible for the provision and communication of the audit strategy
- Responsible for gathering all information from global and local stakeholders in order to update and maintain the PV audit risk tool
- Responsible for implementation and analysis of quality system information from external partners in order to risk assess compliance and audit priority
- Responsible for provision of all information related to the audit module for maintenance of the Pharmacovigilance System Master File (PSMF)
- Responsible for updating all SOPs and associated documentation in order to maintain a harmonized and efficient QMS to support the PV audit program
- Responsible for ongoing implementation of the Global PV audit risk strategy including alignment on a quarterly basis in accordance with PSMF changes.
- Contribute to the team activities for continuous improvement and maintenance of a global GxP compliance platform for reporting, reviewing and trending Global Quality Audit KPIs
- Responsible for provision and communication of trend analysis related to the PV audit program
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.