Pharmacovigilance QA Manager

Our client is a multinational biopharmaceutical company committed to improving the lives of patients worldwide. They seek to deliver truly innovative and life-changing drugs to patients, with a mission as a company to build a major global biopharmaceutical corporation, whilst focusing on the discovery, the development and the commercialisation of products for the treatment of cancer and other severe, immune, inflammatory conditions. During this exciting time of Globalisation and growth, they are currently looking for a Pharmacovigilance QA Manager to join the team based in the UK.

You will be responsible for managing the company-wide pharmacovigilance audit program, performing audits as required, and assisting the Associate Director in the identification of issues and areas of risk. Communicating issues and risks to Senior Management and advise clients on mitigation strategies to correct and prevent further occurrences of identified issues. Interaction internally and externally with clients will be on a global basis.

Other duties will include but are not limited to:

• Implementing, and maintaining an effective pharmacovigilance audit program (global methods, techniques and criteria for establishing metrics)
• Participating in audit the development of Corporate PV audit policies, SOPs, working practices & guidelines
• Conducting/participating in audits as necessary
• Monitoring corrective action plans through use of existing processes e.g. CAPA
• In conjunction with the Associate Director, analysing results of PV audits and communicating issues and areas of risk to Senior and Executive Management
• Consulting with auditees on development and implementation of effective resolution of compliance issues.

• a detailed knowledge of Volume 9A and associated European directives , knowledge of individual EU member state PV requirements, and detailed knowledge of drug safety regulatory requirements in the US, Australia and Japan
• expert knowledge of audit principles and concepts
• excellent interpersonal, facilitation, presentation and communication skills (verbal and written) with demonstrable tact and diplomacy
• a high level of maturity and character
• the ability to function in a team environment
• the ability to lead others.

How to apply for the Pharmacovigilance QA Manager role:

1. Click the button below to raise an email form
2. Attach your CV file to the email
3. Add any covering letter / personal notes to the body of the email
4. Send your completed job application through to us for processing.

Alternatively, for a confidential discussion concerning the Pharmacovigilance QA Manager opportunity you can telephone Amber Burns on +44 (0)1707 259333. Please be sure to quote 10397 in all correspondence relating to this role.