Flexible Working
Learning & Development
Wellbeing

Scientific Officer (CERD) – Medicine Shortages and Borderline Classification, Compliance / Oifigeach Eolaíochta, (CERD) - Ganntanais Leighis & Aicmiú Teorann - Comhlíonadh

Salary €45,279-€75,148 per annum (incremental scale)
Location Hybrid
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This is a Temporary, Full Time vacancy that will close in {x} days at {xx:xx} BST.

The Vacancy

Reporting to the Critical Entities Resilience (CER) Assessor, the role of Scientific Officer is to assist in the coordination of the HPRA approach in relation to its remit as Competent Authority for:

  1. Entities manufacturing pharmaceutical products basic and pharmaceutical preparations as referred to in Division 21 of Section C of Annex 1 to NACE Rev. 2,
  2. Entities manufacturing medical devices on the public health emergency critical devices list, within the meaning of Article 22 of Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022, as amended,
  3. Entities holding a distribution authorisation within the meaning of Title VII of the Medicinal Products Directive,

on a national basis, and where those entities present a significant risk to overall European supply.

The Critical Entities Resilience (CER) Directive has been transposed into Irish law through the European Union (Resilience of Critical Entities) Regulations 2024, which came into effect on October 17, 2024. The CER Directive aims to enhance the resilience of critical entities that provide essential services for vital societal functions or economic activities in the EU.

The Scientific Officer will support the work of the CER Assessor and the Medicines Shortages Coordination Lead in carrying out the responsibilities of the HPRA as Competent Authority, as outlined by the National Strategy on the Resilience of Critical Entities, in taking part in the National Risk Assessment as coordinated by the Office of Emergency Planning (OEP) at the Department of Defence,  and in identifying and engaging with critical entities. The Scientific Officer will also aid in developing appropriate supervisory mechanisms in consultation with the inspections and surveillance teams in Compliance, and Medical Devices and Human Medicines functions.

The role will also involve providing support to projects such as the development of the national medicines supply transparency mechanisms required to integrate effectively with the European Medicines Shortage Platform (ESMP).

The Company

We are the Health Products Regulatory Authority (HPRA) and we regulate medicines and devices for the benefit of people and animals. We are committed to excellence in health product regulation through science, collaboration and innovation.

Our remit and regulatory functions include human and veterinary medicines, clinical trials, medical devices, controlled drugs, blood and blood components, tissues and cells, and cosmetic products.

The Benefits

Flexible
working

Learning & Development

Wellbeing

Employee Assistance Programme

Beneficial Leave Policies

Pension Scheme

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Closing

in X days

{Expiry}