Organisational overview of the Pharmaceutical Sector – Part A Clinical Affairs

The pharmaceutical sector plays an important role in Ireland and is responsible for a significant majority of Irish exports. The following is breakdown of the functions and organisation of the Clinical Affairs department within a typical pharmaceutical company. The clinical affairs department acts on the whole in tandem, with all departments interrelated and working together.

Clinical Affairs Department

Typically the clinical 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 Trials – management of ongoing phase I-III clinical trials.

Regulatory Affairs – management of the preparation and submission of regulatory documentation to the relevant government regulatory bodies – IMB, FDA etc

Medical Information – responsible for the dissemination of technical information regarding current products to primary 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.

Key Job Profiles:

Medical Director

Pharmacovigilance / Drug Safety Officer

Medical Information Officer

Medical Advisor

QA Executive

Medical Science Liaison

Regulatory Affairs Officer

Clinical Research Associate

If you would like any further information please contact

Eamonn O’Raghallaigh MSc, LifeScience.ie – 01 6854848

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