Assessor, Biologics, Human Products Authorisation and Registration
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 mutual recognition, decentralised and national mechanisms, and the other delivering assessments for products authorised through the centralised (EU) mechanism, and for clinical trials.
The position of Assessor of biological quality (CMC) data will be based in the Biological team in the Centralised and Clinical Trials licensing section and will report to the Executive Assessor. The Centralised and Clinical Trials licensing section consists of many scientific disciplines including biological, chemical, clinical, methodology and non-clinical disciplines. The Biological team delivers assessments for products authorised through the centralised (EU) mechanism, and clinical trials.
The Assessor will assist in the evaluation of the quality aspects of applications for human medicinal products of biological origin, in the centralised and clinical trial licensing section, part of the Human Products Authorisation and Registration (HPAR) department.
The Assessor will work closely with and maintain effective working relationships with other members of the Centralised and Clinical Trial Licensing section, and colleagues across the organisation, 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.
This is a technically challenging role, and the Assessor will be expected to call upon their scientific knowledge and expertise. As the biological aspects of regulatory medicine is a rapidly evolving field, the Assessor is expected to adapt to emerging developments, technologies, legislations and support colleagues through ongoing knowledge sharing and dynamic upskilling.
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.
You have already applied for this vacancy, please go to your account to see your progress.
Privacy Policy
Health Products Regulatory Authority Privacy notice for Recruitment
The HPRA has created this data protection notice as the controller of your personal data to demonstrate our firm commitment to privacy and to inform you about the information we collect and process in connection with our recruitment process.
As defined by the General Data Protection Regulation (GDPR) Health Products Regulatory Authority is the Data Controller and ultimately responsible for ensuring the data you provide is kept secure, processed correctly and that you understand your legal rights in relation to the data you provide.
The recruitment software we use via this website is supplied by IRIS Software Group Limited and they are defined as a Data Processor under the GDPR. They will only process your data in accordance with our instructions.
IRIS can be contacted at: 4th Floor Heathrow Approach, 470 London Road, Slough, England, SL3 8QY
For Data Protection enquiries, please contact the Help Desk at support@networxrecruitment.com
What information do we process?
We collect information that is specifically provided by you as part of an application process. We will collect the following (but not limited to):
Name, address, email, telephone number
CV (if applicable) containing work and educational history
Equal opportunities monitoring information (defined as special category data) - this information is purely for statistical analysis and monitoring purposes
Answers to application questions
Any other information you wish to provide in support of your application
Evaluation/scoring records may also be processed if you attend for interview. If your application for employment is successful, personal data gathered during the recruitment process, e.g. information provided by referees, pre-employment medical report, etc., will be transferred to your Human Resources file and retained during your employment.
Legal basis for processing
The legal basis for the processing under the GDPR are:
Article 6(1)b processing is necessary for the performance of a contract to which the data subject is party or in order to take steps at the request of the data subject prior to entering into a contract
Article 6(1)c processing is necessary for compliance with a legal obligation to which the controller is subject
Article 6(1)f processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party, except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child.
Article 9(2)b processing is necessary for the purposes of carrying out the obligations and exercising specific rights of the controller or of the data subject in the field of employment and social security and social protection law in so far as it is authorised by Union or Member State law or a collective agreement pursuant to Member State law providing for appropriate safeguards for the fundamental rights and the interests of the data subject
The legislation we rely on for processing due to a legal obligation is:
Employment Equality Acts, 1998 – 2015
Organisation of Working Time Act, 1997
Employment Permits Act, 2003 to 2014
Terms of Employment (Information) Act,1994
Your personal data is used for the following legitimate interests pursued by the HPRA:
To assess your suitability for employment with us
To enable us to run our business and manage our employment relationship with you effectively, lawfully and appropriately
To protect employees’ rights and interests
To manage the employment contract if your application is successful
To comply with legal obligations and to protect our legal position in the event of legal proceedings against the HPRA
To carry out statistical analysis of our recruitment processes.
What happens if you do not provide us with your information?
You may decline to provide us with your personal data. However, we require relevant information to properly manage our recruitment process, and we may not be able to evaluate or assess your application if you decline to provide us with required personal data
Registering with HPRA recruitment If you choose to register your details with the HPRA,
you may access your profile, correct and update your details, or delete your details at any time. To access, correct, update or delete your details, please access your personal profile by using the secure login. Within your candidate account, you can also use the ‘Download Data’ feature to generate an XML file of the current data we hold on you that you have provided and/or have access to within the account.
How is your information processed and shared?
Your information may be shared with organisations who provide services to the HPRA, e.g. HR advisors, expert panel members, legal advisors.
The HPRA uses third party service providers and suppliers (also known as data processors) in order to carry out both our regulatory functions and other related matters. These third parties process personal data on behalf of the HPRA and appropriate arrangements are in place with them to protect personal data.
Your data will be transferred to third countries including the UK, USA and India. The European Commission has granted an adequacy decision to the UK which recognises that the country provides an equivalent level of data protection to that guaranteed under EU law. Other measures to protect your data are in place in relation to data transferred to the US and India and you may contact the HPRA at the details below or our data processor IRIS-Networx for further information on these measures.
Your personal data will be stored for 18 months after the vacancy you apply for has closed. After this period, it will be fully anonymised.
The HPRA fully respects your right to privacy and treats all personal information with the appropriate standards of security and confidentiality.
What are your rights under data protection law?
Data protection legislation provides you with the following rights regarding the processing of your personal data:
the right to request access to your data
the right to request your data be rectified or erased
the right to request processing of your data be restricted
the right to object to processing
the right to lodge a complaint with the Data Protection Commission
How to contact us
For more information or to make a request regarding your personal data under data protection law, please submit your request in writing or via email to: Data Protection Officer
Health Products Regulatory Authority, Kevin O’Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2
Tel: +353 (1) 676 4971
Fax: +353 (1) 676 7836
Email: dataprotectionofficer@hpra.ie
Please provide sufficient information in your request to enable us to deal with your query.
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