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Details

Medical Officer


Reference:ADNV-348705 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Medical Advisor, Medical Director

Medical Officer
Reporting to the Vigilance Assessment Manager, the role of the Medical Officer is to evaluate and regulate the safety and efficacy of medicinal products in Ireland and in the European Union. Provide technical support to the relevant line managers in order to facilitate the efficient licensing of medicinal products, safety monitoring of medicinal products and the approval of clinical trials of medicinal products.

Responsibilities
• Evaluation of the safety and efficacy of medicinal products 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 medicinal products as well as consideration of the public health consequences of their use
• Assessment of applications for clinical trials with medicinal products
• Post marketing signal detection and evaluation activities using available databases and evaluation of signals from a range of data sources including the published literature and epidemiological studies
• Assessment of Pharmacovigilance Plans and Risk Minimisation Plans as well as evaluating the effectiveness of implemented measures in the context of ongoing risk management
• Assessment of vigilance/compliance/ technical files relating to medical devices
• Liaise with colleagues, applicants, regulatory authorities and other relevant bodies, healthcare professionals and the community
• Provide technical information, advice and guidance to colleagues and relevant bodies
• Participate at all levels in the formulation and preparation of regulatory policies, guidelines, legislation and opinions
• Monitoring the safety of authorised medicinal products (pharmacovigilance) by reviewing periodic safety update reports (PSURs), follow-up measures, adverse reactions reports and by checking literature and reports in relation to clinical experience, and by assisting with side effect and quality defect reports as necessary.
• Assessment of Risk Management Plans, Post Authorisation Safety Study protocols and reports, EU safety Referrals and provide support to the medical devices vigilance and compliance section

Requirements
• Candidates must be registered with the Medical Council in Ireland
• Be a registered medical practitioner with a minimum of two years satisfactory service in clinical practice (after becoming entitled to full registration)
• Excellent interpersonal and communication skills
• Have an additional undergraduate or postgraduate qualification in a relevant scientific discipline
• Published research in the academic, clinical or industrial field of medicine
• Evaluation of medicinal products or medical devices in the industrial, government authority, academic or clinical situation
• Good understanding of methodology and biostatics in pharmaceutical medicine
• Good understanding of pharmacokinetics and pharmacodynamics
• Experience or a good understanding of epidemiology, pharmacovigilance or risk minimisation



If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252