Medical Officer - Infectious Diseases, Clinical Assessent - HPAR

Closing date for applications: 01/02/2021

 ROLE SUMMARY

The Medical Officer-Infectious Diseases will work within the Human Products Authorisation and Registration (HPAR) department (assessment and licensing activities).

The role of the Medical Officer is the evaluation and regulation of the safety and efficacy of medicinal products (medicines) in Ireland and the European Union, to provide technical support to the relevant line managers, and to the Director of Human Products Authorisation and Registration in order to facilitate the efficient authorisation of medicinal products and the approval of clinical trials of medicinal products.  

The following key activities are indicative of the range of duties to be undertaken by the Medical

Officer:

• Scientific evaluation of the pharmacology, safety & efficacy of medicinal products (in particular antimicrobials, antivirals and vaccines) 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, in particular antimicrobials, antivirals and vaccines.
• Support the HPRA’s strategic approach to assisting the development of national clinical research infrastructure (clinical trials) for infectious diseases, including COVID-19.
• Assisting in the development and expansion of the HPRA’s strategic approach to the assessment medicines, in particular antimicrobials and antivirals and vaccines.
• Providing leadership, motivation, encouragement and effective management to reporting staff; maintenance of a positive working environment and relationships.
• Technical liaison with HPRA colleagues, applicants, regulatory authorities and other relevant bodies, healthcare professionals and the community.
• Provision of technical information, advice, and guidance to HPRA colleagues, relevant bodies and individuals.
• Representing the Authority on national and international bodies, especially European Bodies.
• Participation at all levels (Authority, national and international) in the formulation and preparation of regulatory policies, guidelines, legislation and scientific opinions.