Medical Officer, Vigilance Assessment - Human Products Monitoring

Closing date for applications: 20/09/2018

The Medical Officer assignment will be to the Human Products Monitoring (HPM) department (post-marketing activities, and pharmacovigilance activities).

Reporting to the Vigilance Assessment Manager, the role of the Medical Officer is the post marketing evaluation and regulation of the benefits and risks of medicinal products in Ireland and the European Union to provide technical support the Director of Human Products Monitoring in order to facilitate the effective safety monitoring of medicinal products.

The following key activities are indicative of the range of duties to be undertaken by the Medical Officer:
o Scientific evaluation of the benefit-risk profile of medicinal products throughout their life-cycle and evaluating the need for, the feasibility of and the effectiveness any post-marketing pharmacovigilance activities and risk minimisation measures as well as consideration of the public health implications of same
o Post marketing signal detection and evaluation activities for medicinal products using available databases and evaluation of signals from a range of data sources including the published literature and epidemiological studies and providing advice and support for such activities
o Assessment of Pharmacovigilance Plans, including study protocols, and Risk Minimisation Plans as well as evaluating the effectiveness of implemented measures in the context of ongoing risk management.
o Assessment of Periodic Safety Update Reports (PSURs)
o Assisting in the development and expansion of the HPRA’s strategic approach to the post-marketing evaluation, monitoring and optimization of benefit-risk profile of medicines, including innovative medicines and medicines used in the area of unmet medical need.
o Technical liaison with Health Product Regulatory Authority (HPRA) colleagues, applicants, regulatory authorities and other relevant bodies, healthcare professionals and the community
o Provision of technical information, advice, and guidance to HPRA colleagues, relevant bodies and individuals
o Representing the HPRA on national and international bodies, especially European Bodies
o Participation at all levels (HPRA, national and international) in the formulation and preparation of regulatory policies, guidelines, legislation and opinions

Role Profile      Application form


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