Closing date for applications: 08/07/2022
Role summary
The Pharmaceutical Assessor will work as part of the Pharmaceutical Assessment section in the Human Products Authorisation and Registration (HPAR) department and will evaluate the quality aspects of new applications for human medicinal products and variations to/renewals of 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 HPAR department to ensure effective co-ordination and co-operation across all areas of assessment and to ensure that the objectives of the HPAR department are met.
The Pharmaceutical Assessor will maintain effective working relationships with colleagues in other departments of the HPRA and with HPRA stakeholder representatives to ensure that cross functional issues requiring pharmaceutical assessment involvement are adequately supported.
Key Responsibilities
Technical objectives:
-Conducting scientific evaluation of quality data submitted in support of marketing authorisation/variation/renewal applications containing new chemical entities or established active ingredients for human medicinal products or homeopathic medicines. This includes, but is not limited to, data on the manufacture and control of drug substances and drug products e.g. formulation, process validation, analytical methods, analytical validation and stability studies.Detailed assessment reports summarising these evaluations may need to be prepared for submission to other EU member states.
-Conducting scientific evaluation of quality data submitted in support of:
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National applications for marketing authorisations
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Centralised applications for marketing authorisations when the HPRA is acting as rapporteur, co-rapporteur or peer reviewer on behalf of the EMA
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EU applications when the HPRA is acting as Reference Member State in a mutual recognition or decentralised procedure
For more information please refer to the role profile below. Applications (Application form and CV) should be sent directly to our recruitment inbox jobs@hpra.ie
Role Profile Application form