Vigilance Assessor
Our Dublin based client requires a Vigilance Assessor to join their team. The successful candidate will be responsible for the post marketing evaluation and regulation of the benefits and risks of medicinal products in Ireland and the EU.


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
• Provide technical support to the team lead in order to facilitate the effective safety monitoring of medicinal products
• Adverse Event detection activities using available databases with integration of quantitative and qualitative approaches
• Evaluation of adverse events from a range of data sources including the published literature and epidemiological studies
• Assessment of Pharmacovigilance Plans including study protocols and amendments to protocols
• Interpretation of data from post-authorisation studies and clinical trials
• Assessment of Risk Minimisation Plans and working with relevant stakeholders to evaluate the effectiveness of implemented measures
• Communicate risk initiatives by providing scientifically rigorous and consistent information to promote the safe and effective use of medicines
• Assessment of Periodic Safety Update Reports (PSURs)
• Technical liaison across cross-functional teams, applicants, regulatory authorities, healthcare professionals and the community

• Primary degree in pharmacy or other closely related scientific discipline e.g. clinical pharmacology
• Have at least 2 years relevant experience
• Postgraduate qualification inpharmacoepidemiology, medical statistics or other closely related scientific discipline, or currently be studying for a postgraduate qualification in these areas
• Knowledge and experience of clinical pharmacology
• Knowledge and experience in the use of medicinal products in the clinical setting
• Previous publications in academia, clinical or industrial field of medicine
• Experience in pharmacovigilance and risk management
• Excellent data analysis skills including the use of statistical packages