Medical Officer –Clinical Assessment – Human Products Authorisation and Registration

Closing date for applications: 25/08/2022

Role Summary

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

The Medical Officer will provide a clinical assessment and consultancy resource to the Human Products Authorisation and Registration (HPAR) department, and other departments within the HPRA, as required.

The Medical Officer will report to a Senior Medical Officer or a Clinical Assessment Manager in the HPAR Department.

 

Key Responsibilities

Technical Objectives

  • Assessment of pharmacology, safety and efficacy data submitted in support of applications for marketing authorisation, variations or renewal for medicines.

  • Assessment of safety and efficacy data submitted in support of applications to conduct clinical trials.

    Analysis of risk-benefit profiles of applications for marketing authorisation and clinical trials, including the preparation and presentation of reports.

  • Participating in the implementation of the HPRA’s Strategic Plan, and assisting in the development of new strategies

  • Technical liaison with HPRA colleagues, applicants, regulatory authorities and other relevant bodies, healthcare professionals and the community.

  • 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.

  • Review of safety information originating from clinical trials including annual safety reports, suspected serious unexpected adverse reactions (SUSARs), preparation and presentation of reports.

  • Involvement in European Medicines Agency (EMA) scientific advice/protocol assistance procedures, and national scientific advice procedures, if required

 

For more information please refer to the role profile below. Applications should be submitted via the HPRA Recruitment Portal.


Role Profile                         Application form



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