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Pharmacovigilance QA Manager

Posted - 11/07/2009
Company Matchtech Group Plc      
Job Type Contract
Salary $5,000 per hour
Location United Kingdom
Region: Northern Europe
Education Any
Work Experience Any
Job Reference
Details QA Manager required with experience in Pharmacovigilance to join a leading pharmaceutical company.

Our client is a leading pharmaceutical manufacturer. They are currently looking for an experienced Pharmacovigilance (PV) QA Manager.

This role will work within the Quality Assurance Department based in Cambridge and report to the Head of Quality Assurance. The objective is to support the European Qualified Person for Pharmacovigilance.

The role requires a good working knowledge of the various European Pharmacovigilance-related regulations and guidance documents, and will be responsible for managing and implementing systems auditing throughout the group of independent associate companies within Europe. Furthermore there is the potential to extend this responsibility to our global associates.

Hands-on practical experience of working within the Pharmacovigilance field is essential; however auditing experience, while not an essential pre-requisite for the job, would be an advantage.

Summary of Duties:

Develop, implement and manage a local pharmacovigilance systems audit schedule
Audit of associate company pharmacovogilance systems
Ensure regulatory authority PV inspection readiness and to lead PV regulatory inspections
Preparation of, and reporting on implementation of corrective action plans to the EU Qualified Person for Pharmacovigilance
Audit of third party suppliers to corporate pharmacovigilance systems
Provide consultancy on compliance to current pharmacovigilance regulations / guidance
Provide input to training programmes on pharmacovigilance

Experience / Qualifications Required:

As a minimum you will need a life sciences degree, or equivalent level/experience and experience of working within either a pharmacovigilance or GCP environment. You will also have extensive knowledge of European Pharmacovigilance legislation and associated guidance documents.

MatchTech Group Plc is acting as an Employment Agency in relation to this vacancy.
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