Closing date for applications: 05/03/2023
Role Summary
The Vigilance Assessor will work as part of a dynamic multi-disciplinary team within the Human Products Monitoring (HPM) Department of the HPRA. They will be responsible for monitoring the benefit-risk profile and for assessing risk management planning activities of medicinal products in Ireland and in the European Union in the post-marketing setting.
The Vigilance Assessor will be closely involved contributing to and leading safety assessments conducted by the HPRA both nationally and as part of the European network and will actively support the HPRA’s contribution to the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee.
The key activities of the role will involve:
-Scientific evaluation of cumulative and emerging data on the risks of medicinal products from various post marketing sources including clinical studies, pharmacovigilance databases and scientific literature to facilitate the timely detection and assessment of any safety concerns.
-Consideration of the impact of such evaluations on proactive risk management planning for the medicinal product including the need for, design and evaluation of post-authorisation safety studies.
-Regulatory communication of such risks to healthcare professionals and patients in order to ensure the safe and rational use of medicines on the Irish market.
The position may be suitable for an individual with a pharmacy/life sciences background with relevant clinical experience together with experience in conducting literature reviews, data analysis and critical appraisal to support clinical decision-making. Candidates should have a demonstrated ability for technical scientific report writing. Preference will be given to candidates with research experience, in particular in the area of pharmacoepidemiology or similar discipline.
For more information, please refer to the role profile below. Applications should be submitted via the HPRA Recruitment Portal
Role Profile Application form