Closing date for applications: 22/07/2020
ROLE SUMMARY
The Vigilance Assessor will work within the Human Products Monitoring (HPM) department in relation to vigilance of post-marketing and pharmacovigilance activities.
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.
The following key activities are indicative of the range of duties to be undertaken by the Vigilance Assessor:
- 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 post-authorisation safety 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
For more information please refer to the role profile below. Applications should be submitted via the HPRA Recruitment Portal
Role Profile HPRA Recruitment Portal Application Form