Vigilance Assessor

CPL

DUBLIN SOUTH

On behalf of my client, we are actively working with them for a new role of Vigilance Assessor. 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 in order to facilitate the effective safety monitoring of medicinal products. The following key activities are indicative of the range of duties to be undertaken by the Vigilance Assessor: 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 post-authorisation safety 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 the colleagues, relevant bodies and individuals. o Representing the organisation on national and international bodies. o Participation at all levels (national and international) in the formulation and preparation of regulatory policies, guidelines, legislation and opinions. QUALIFICATIONS AND EXPERIENCE. - To be considered for this post, candidates must: o Have a primary degree in pharmacy or other closely related scientific discipline. o Have at least 4 years relevant experience (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 the interpretation of pharmacoepidemiological data and ability to apply this to clinical decision-making and risk minimisation. o Have excellent interpersonal skills. o Be of good character. - In addition to this the ideal candidate will also have one or more of the following; o Experience in working in the field of pharmacoepidemiology and/ or pharmacoepidemiological research. 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. For full job spec email Tina at tdunne@thornshaw.com or call +1 2784671. Thornshaw is a division of the CPL group. www.thornshaw.com.

1387 days ago