Vigilance Assessor

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The role of the Vigilance Assessor is the post marketing evaluation and regulation of the benefits and risks of medicinal products in Ireland and the European Union, to provide technical support to the Director of Human Products Monitoring in order to facilitate the effective safety monitoring of medicinal products.

This is a fantastic opportunity to join an accredited body in the Public Sector.

Key Responsibilities:

* Signal detection activities using available databases and with integration of quantitative and qualitative approaches for signal management in accordance with EU guidance

* Evaluation of signals from a range of data sources including the published literature and epidemiological studies

* Assessment of Pharmacovigilance Plans including study protocols and amendments to protocols

* Assessment of Risk Minimisation Plans and working with relevant stakeholders to evaluate the effectiveness of implemented measures

* Assessment of Periodic Safety Update Reports (PSURs)

* Contributing to the assessment of data in the context of ongoing risk management and safety reviews (including referrals)

* Assisting with the effective implementation of the HPRA quality management system with the Human Products Monitoring department

Experience and Qualifications:

* Primary degree in pharmacy or other closely related scientific discipline

* Minimum of 3 years' relevant experience in research, health care, industry or regulatory environment (acquired after the qualification required above)

* Comprehensive knowledge and experience of clinical pharmacology

* Comprehensive knowledge and experience in the use of medicinal products in the clinical setting

* Performed or published research in the academic, clinical or industrial field of medicine

* Sound understanding of and a proven track record in the interpretation of pharmacoepidemiological data and ability to apply this to clinical decision-making and risk minimisation

* Flexible working hours

* Public Service Pension Scheme

* Salary: EUR61,031

Not sure yet? No CV ready? get in touch for more information.

To find out more about Real please visit www.realstaffing.com

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales