Reporting to the Clinical Assessment Manager, the role of the Senior Medical Officer is to: lead the evaluation and regulation of the safety and efficacy of medicinal products (medicines) in Ireland and the European Union; lead in the provision of technical support to the Clinical Assessment Managers, and other areas of the organisation on relevant issues relating to the safety and efficacy of medicines in order to facilitate their efficient licensing; assist in the strategic development of the organisation with respect to increasing its profile and recognition within Europe in the assessment of medicines
The following key activities are indicative of the range of duties to be undertaken by the Senior Medical Officer:
o Leading the scientific evaluation of the safety & efficacy of medicines which are the subject of new applications; analysis of their benefit/risk profiles; reporting and forming conclusions in respect of their suitability for use as medicines as well as consideration of the public health consequences of their use.
o Reviewing the on-going efficacy of authorised medicines; analysis of their benefit/risk profiles; reporting and forming conclusions in respect of their suitability for use as medicines as well as consideration of the public health consequences of their use.
o Leading the assessment of applications for clinical trials involving medicines. Coordination of the assessment of such clinical trials including required external experts' liaison.
o Leading the clinical assessment of applications for Scientific Advice relating to medicines.
Strategic Management Quality Management Performance Management Coaching and Development Communications/Customer Service
QUALIFICATIONS AND EXPERIENCE
- To be considered for this post, candidates must:
o be registered with the Medical Council in Ireland
o be a registered medical practitioner with a minimum of five years satisfactory service in clinical practice (after becoming entitled to full registration)