Closing date for applications: 31/01/2019
*The HPRA are currently accepting applications for a Vigilance Assessor role on an on-going basis. Confirmation of interview invitation will determined upon receipt of applications.
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 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
- 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
- Assessment of Periodic Safety Update Reports (PSURs)
- Technical liaison with the HPRA colleagues, applicants, regulatory authorities and other relevant bodies, healthcare professionals and the community
- Provision of technical information, advice, and guidance to the HPRA colleagues, relevant bodies and individuals
- Representing the HPRA on national and international bodies
- Participation at all levels (HPRA, national and international) in the formulation and preparation of regulatory policies, guidelines, legislation and opinions
Role Profile Application Form