Clinical Compliance Officer
A growing pharmaceutical company is seeking a Clinical Compliance Officer to work on European multi-country trials. This company is currently in the development phases on a range of products for treatment of renal diseases. The company is part of a group which employs over 16,500 people globally. They offer a friendly, supportive working environment and opportunities to develop your skills.
As a Clinical Compliance Officer you will be responsible for ensuring compliance with regulations in place to protect patient safety and help manage the reporting procedure to regulatory authorities. Your key tasks will include;
•Participating in the selection of third party vendors such as CRO’s by auditing potential suppliers.
•Working with the regulatory compliance manager to advise the company on how best to manage their pharmacovigilance systems.
•Managing and testing emergency procedures including the recall of medication, SAE reporting, out of hours cover for patients etc
•Establishing and managing a comprehensive GCP, GLP and cGMP quality assurance function within the company
Suitable candidates for this position should have a degree in a scientific and have experience of working in industry as a scientist. You will also need a detailed knowledge in EU Directives and FDA clinical guidelines. You should be familiar with Good Laboratory Practice and Good Manufacturing Practice guidelines and have experience as an auditor.
This is a fantastic time to join this growing company where you will be offered the chance to work in a team of motivated professionals. You will be offered an excellent package and be supported and developed in your career.
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