Closing date for applications: 19/02/2023
Role Summary
Reporting to the Pharmacovigilance Manager, the Pharmacovigilance Surveillance Assessor will work within the Human Products Monitoring (HPM) department in relation to safety monitoring and pharmacovigilance activities.
The role of the Pharmacovigilance Surveillance Assessor is to lead the technical team responsible for the review and evaluation of national, Individual Case Safety Reports (ICSRs) within the Pharmacovigilance section; to ensure HPRA obligations and requirements with regard to reporting are met in an appropriate and timely manner; to provide technical support and guidance in the review and evaluation of ICSRs; to appropriately collate, evaluate and present national data; to provide input and support for follow up of ICSRs, responses to technical and other queries; to support team organisation and activities to efficiently and effectively manage the workload and achieve required levels of performance; and to respond effectively to changes in the internal and external environment.
The Pharmacovigilance Surveillance Assessor will also work closely with other members of the Pharmacovigilance and Vigilance Assessment sections and the overall HPM department, as well as other HPRA departments, particularly the Human Products Authorisation and Registration (HPAR) and Compliance departments.
The following key activities are indicative of the range of duties to be undertaken by the Pharmacovigilance Surveillance Assessor:
-
Leading and supervising the technical team dealing with adverse reaction and event reporting in line with the goals and objectives of the Pharmacovigilance section and the HPM department
-
Acting as a subject matter expert with regard to case processing and associated regulatory and scientific guidance
-
Providing technical support in the review, evaluation and follow up of national, Individual Case Safety Reports (ICSRs)
-
Monitoring trends in national reporting of ICSRs
-
Highlighting ICSRs and national reporting experience, with overviews of cumulativedata, as appropriate
-
Collating, evaluating and presenting summary overviews ofnational reporting data
-
Managing and monitoring HPRA compliance with ICSR reporting standards and timelines
-
Actively managing the ICSR workload, through case allocation and follow up, development/enhancement of processes to facilitate throughput and proactive preparation for case processing and management in the context of report surges arising from stimulated reporting activities.
For more information, please refer to the role profile below. Applications should be submitted via the HPRA Recruitment Portal
Role Profile Application form