Pharmaceutical Assessor, Pharmaceutical Assessment – Veterinary Sciences

Closing date for applications: 21/05/2023

Role Summary

The Pharmaceutical Assessor will work as part of the Pharmaceutical Assessment section in the Veterinary Sciences (VS) department and will assist in the evaluation of the pharmaceutical aspects of new applications for veterinary medicinal products and variations to existing authorisations for pharmaceutical products containing new chemical entities or established active ingredients.

The Pharmaceutical Assessor will work closely and maintain effective working relationships with the other members of the Pharmaceutical Assessment section, and with members of the VS department as a whole, to ensure effective co-ordination and co-operation across all areas of assessment and to ensure that the objectives of the VS department are met.

The Pharmaceutical Assessor will maintain effective working relationships with colleagues in other sections and departments of the HPRA, and with stakeholders, to ensure that Pharmaceutical Assessment issues requiring cross-functional input are effectively investigated and followed up on.

Key Responsibilities

Technical Objectives

• Conducting scientific evaluation of pharmaceutical data submitted in support of applications for marketing authorisation for veterinary medicinal products containing new chemical entities or established active ingredients. Analysis of their risk/benefit profiles; reporting and forming conclusions in respect of their suitability for use as veterinary medicinal products as well as consideration of the public health consequences of their use.

• Conducting scientific evaluation of pharmaceutical data submitted in support of:

  • National applications for marketing authorisations, including Parallel Products

  • EU applications when the HPRA is acting as Reference Member State in a mutual recognition, decentralised or subsequent recognition procedure

  • Centralised applications to the EMA for marketing authorisations when the HPRA is acting as rapporteur, co-rapporteur or peer reviewer on behalf of the EMA

  • Centralised scientific advice applications where the HPRA is acting as coordinator on behalf of the EMA

• Preparation of assessment reports on applications for and variations to marketing authorisation for veterinary medicinal products and submission of reports to other EU member states when the HPRA is acting as Reference Member State in a mutual recognition or decentralised procedure

• Analysis in the context of public health, of risk-benefit profiles in respect of applications for marketing authorisations; making recommendations and preparation and presentation of reports to the Board, Advisory Committees and Sub-Committees or the Management Committee of the HPRA, and/or the CVMP or their representative working parties

• Assisting the Pharmaceutical Assessment Manager in ensuring the accuracy of relevant data inputted in the computer databases and information systems of the HPRA