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Details

Vigilance Assessor


Reference:KS-APPU-406517 Location: Dublin
Qualification:DoctorateExperience:1-2 Years
Job Type:Fixed Term ContractSalary: Not Disclosed

Reporting to the Director of Human Products Monitoring the role of the Vigilance Assessor is to provide post marketing evaluation and regulation of the benefits and risks of medicinal products in Ireland and the European Union and to provide technical support to the Director of Human Products Monitoring in order to facilitate the effective safety monitoring of medicinal products. A degree in Pharmacy or a PhD with 3 years research experience is essential for this role.

Role/Responsibilities:
o Signal detection activities using available databases and with integration of quantitative and qualitative approaches for signal management in accordance with EU guidance
o Evaluation of signals from a range of data sources including the published literature and epidemiological studies
o Assessment of Pharmacovigilance Plans including study protocols and amendments to protocols o Interpretation of data from post-authorisation studies and clinical trials
o Assessment of Risk Minimisation Plans and working with relevant stakeholders to evaluate the effectiveness of implemented measures
o Contribution to transparency and risk communication initiatives through the provision of scientifically rigorous and consistent information to promote the safe and effective use of medicines o Assessment of Periodic Safety Update Reports (PSURs)
o Technical liaison with colleagues, applicants, regulatory authorities and other relevant bodies, healthcare professionals and the community
o Provision of technical information, advice, and guidance to colleagues, relevant bodies and individuals
o Representing the organisation on national and international bodies
o Participation at all levels (local, national and international) in the formulation and preparation of regulatory policies, guidelines, legislation and opinions

Qualifications/Experience:
o Have a primary degree in pharmacy or other closely related scientific discipline
o Have a minimum of 3 years’ relevant experience in research, healthcare, industry or regulatory environment (acquired after the qualification required above)
o Have comprehensive knowledge and experience of clinical pharmacology
o Have comprehensive knowledge and experience in the use of medicinal products in the clinical setting
o Have performed or published research in the academic, clinical or industrial field of medicine
o Have experience or a good understanding of pharmacovigilance and risk management
o Have a 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
o Excellent interpersonal skills
o Be of good character
o Have or be currently undertaking a postgraduate qualification in pharmacoepidemiology, medical statistics or other closely related scientific discipline
o Excellent data analysis skills including the use of statistical packages
o Experience in working in the field of pharmacoepidemiological research is desirable

If you would like further Information you can contact the recruiter directly:

Karen Shiel | Tel: +353 (0) 1 5079256