Flexible Working
Learning & Development
Wellbeing

Assessor, Methodology (Pharmacokinetics) – Acting, Centralised and Clinical Trials Licensing – Human Products Authorisation & Registration / Measúnóir, Modheolaíocht (Cógaschinéitic), Gníomhach, Ce

Salary €77,045 - €89,345 per annum
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

The Human Products Authorisation and Registration (HPAR) Department provides human medicines licensing services to the Health Products Regulatory Authority (HPRA). HPAR is structured with two main technical sections - one delivering assessments for products authorised through the centralised (EU) mechanism and clinical trials and the other delivering assessments for products authorised through mutual recognition, decentralised and national mechanisms.

The position of Assessor, Methodology (Pharmacokinetics) – Acting will be based in the Methodology team in the Centralised and Clinical Trials licensing section and will report to the Executive Assessor (Methodology). The Methodology team delivers assessments for products authorised through the centralised (EU) mechanism and clinical trials. The Methodology team consists of clinical pharmacology/pharmacokinetics assessors, and biostatisticians/statistical assessors.

The Assessor, Methodology (Pharmacokinetics) - Acting will use their scientific and professional expertise to lead the assessment and review of the clinical pharmacology aspects of marketing authorisation applications and clinical trials. The assessment involves report writing, contributing to the benefit-risk assessment, making recommendations and clinical integration. The Assessor will be expected to critically analyse both clinical & complex scientific information, make sound judgments on its value and write informative reports for a multi-disciplinary readership.

The Assessor will work closely and maintain effective working relationships with colleagues in the Methodology team, the section and the HPAR department, to ensure effective co-ordination across all areas of assessment and ensure the objectives of the HPAR department are met. The Assessor will maintain effective working relationships with colleagues in other sections and departments of the HPRA, to ensure effective conduct on issues requiring cross-functional input.  

The Assessor will have the opportunity to participate in the European Medicine Agency’s (EMA) Methodology European Specialised Expert Community, where the Assessor will have opportunity to knowledge share and interact with colleagues in the topic areas of clinical pharmacology, modelling & simulation, and other key areas of methodology.

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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Published

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Closing

in X days

{Expiry}