Pre-clinical Assessor, Clinical Assessment – Human Products Authorisation and Registration

Closing date for applications: 19/03/2023

Role Summary

The Pre-clinical Assessor will be responsible for the examination and evaluation of the pre-clinical (pharmacology and toxicology) components of applications related to medicinal products (medicines) submitted to the HPRA, and making recommendations in respect of likely hazards associated with the use of the relevant substances in humans, and their potential risk to the environment.

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

The Pre-clinical assessor will report to the Executive Preclinical Assessor.

 

Key Responsibilities

Technical Objectives

  • Examination and evaluation of the pharmacological and toxicological components of applications submitted to the HPRA

  • Assessment of the risks for humans associated with or derived from the use of medicines, herbal medicines, cosmetics and medical devices on the basis of extrapolation from the results of pharmacological and toxicological studies

  • Assessment of the suitability of methodologies used, of validity and significance of results obtained for hazard identification

  • Critically assess the bioanalytical methods applied to measure drug concentrations in biological matrices for risk assessment, including their validation

  • Preparation and/or review of assessment reports describing the pharmacological and toxicological characteristics of medicinal products, relevant substances, and relevant data in published literature, during participation in national and European authorisation procedures

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

  • Provide support to the clinical and pharmaceutical assessment of applications, both pre and post authorisation

  • Provision of support to the pharmacovigilance unit in the development of pharmacovigilance and risk minimisation plans in so far as they refer to pre-clinical information on products for human use

  • Assessment of environmental risk assessment reports as submitted for authorisation of medicinal product use

  • Provide internal technical expertise to Medical Device and Compliance departments, as required

  • Attendance at meetings on behalf of the HPRA at home or abroad




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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