Purpose of role:
The Licensing Division is responsible for the quality, safety and efficacy evaluation of all applications for medicinal products to be authorised for the UK through national and EU Community procedures. To reflect the importance of pharmacokinetic data in the evaluation of clinical safety and efficacy and the increasing use of pharmacometrics in drug development we have a new post for a pharmacokineticist in the Division to integrate knowledge of pharmacokinetics into the assessment of safety and efficacy.
Your scientific and professional expertise in pharmacokinetics will be vital in this challenging role, as you will work alongside clinical pharmacologists, clinicians and biostatisticians to evaluate the efficacy and clinical safety of a range of products including the latest new drugs, generic drugs and clinical trial products. You will provide advice on pharmacokinetic issues to colleagues within the Division and will review pharmacokinetic aspects of clinical trial data, preparing reports and recommendations which are highly influential in bringing new medicines to the market. You will need to interact with colleagues in other European regulatory agencies, the European Medicines Agency and to present your considerations to UK and European multi-disciplinary advisory committees. You will also be involved in the development of new regulatory guidelines and the provision of scientific advice on drug development programmes.
read more - http://www.mhra.gov.uk/Aboutus/Workingforus/Currentjobvacancies/CON140825