Senior Medical Officer Nr ref.: /JOBS.pl Senior Medical Officer, Clinical Assessment This is a 3 year contract role. ROLE SUMMARY 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. KEY RESPONSIBILITIES 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) *Oncology and/or haematological oncology experience essential o have an additional postgraduate qualification in a relevant discipline o have detailed knowledge and experience of managing EU authorisation procedures for medicines o have experience in the management of a multi-disciplinary team o have excellent interpersonal and communication skills o be of good character - In addition to this the ideal candidate will also have one or more of the following; o clinical training in oncology and/or haematological oncology o published research in the academic, clinical or industrial field of medicine o evaluation of medicines in the industrial, government authority, academic or clinical situation o good understanding of methodology and biostatistics in pharmaceutical medicine o good understanding of pharmacokinetics and pharmacodynamics and processes for assessment of biological and biosimilar medicines For a full Job Spec please contact Linda on or email Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .
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