close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished

Organisational Structure

The following is breakdown of the functions and organisation of the Medical Affairs department within a typical pharmaceutical company. The Medical Affairs department acts on the whole in tandem, with all departments interrelated and working together.

Typically the medical affairs department is headed up by the Medical Director. They are responsible for the following departments.

  • Pharmacovigilance- reporting of SAE's and other pharmacovigilance data of current drugs on the market and also preliminary data for drugs in development.

  • Clinical Research- management of ongoing phase II-IVb clinical trials.

  • Regulatory Affairs- management of the preparation and submission of regulatory documentation to the relevant government regulatory bodies - IMB, FDA etc. New licence applications and/or indication applications.

  • Medical Information- responsible for the dissemination of technical information regarding current products to primary / secondary care providers and academia. Responsible for the training of sales force with regards to technical information and also the dissemination of information internally.

  • Quality Assurance- responsible for the development and management of quality systems within the department - writing up SOP's and training other stakeholders in their implementation and application.