A global pharmaceutical company is looking for an experienced Pharmacovigilance professional to join them as a Senior Manager of Pharmacovigilance Quality Assurance.
The main task is to manage and perform audits with focus on Pharmacovigilance audits. Additional tasks are to support the continuous improvement of the Global Quality System, the inspection management, the regulatory intelligence activities, the SOP and WP management, the validation activities and the project liaison activities.
Key Resposibilitie Include:
- Implement & maintain the global pharmacovigilance risk-based strategy for audit and risk assessment activities
- Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and lessons learned from audit/ inspection
- Plan, supervise, conduct, and support internal and external GxP audits
- Follow-up on the development, implementation and completion of corrective and preventive actions with internal and external auditees
- Develop and support global compliance training procedures in collaboration with other affiliate sites and provide training in the area of expertise as assigned.
- Support the preparation for GxP inspections
- Support the responses to Regulatory Authorities
- Maintain a tracking tool for audits, findings and corrective and preventive actions
- Maintain an overview over the relevant regulatory requirements and state-of-the-art knowledge of development in the professional regulatory environment to be able to provide guidance for timely adaptation of the company's procedures.
- Act as quality liaison for assigned projects
This role involves 20-30% travel
To be considered you need at least 6 years of Pharmacovigilance and preferably with experience of Pharmacovigilance Quality Assurance
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales