Scientific Officer, Pharmaceutical Assessment – HPAR

Closing date for applications: 18/05/2022

Role summary

The Scientific Officer will work as part of the Pharmaceutical Assessment Section in the Human Products Authorisation and Registration (HPAR) Department and will assist in the evaluation of the quality aspects of applications for renewal or variation of existing marketing authorisations for human medicinal products or applications for Parallel Product Authorisations and other activities relating to the authorisation and registration process.

The Scientific Officer will work closely and maintain effective working relationships with the other members of the section, and with members of the HPAR 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 HPAR department are met.

The Scientific Officer will maintain effective working relationships with colleagues in other Sections and Departments of the HPRA to ensure that issues requiring cross-functional input are effectively managed.

Key Responsibilities

Technical Objectives

  • Conducting scientific evaluation of quality data submitted in support of marketing authorisation applications, and variations to or renewals of marketing authorisations, for human medicinal products in accordance with national, mutual recognition and decentralised procedures

  • Conducting scientific evaluation of applications for parallel product authorisations and variations to parallel product authorisations

  • The review of Article 61(3) notifications (EU Council Directive 2001/83/EC) submitted to HPRA in relation to human medicinal products.

  • The preparation and maintenance of lists of interchangeable medicinal products as per the Health (Pricing and Supply of Medical Goods) Act 2013

  • Participation in, and/or coordination of, the Naming Review Group, if requested

  • Working with the managers of the HPAR department in ensuring the accuracy of relevant data inputted in the computer databases and information systems of the HPRA

  • Gathering and evaluation of scientific data in relation to authorisation and registration processes, as required, and in line with business needs

 

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

 



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