Closing date for applications: 15/02/2023
Role Summary
Reporting to the Pharmacovigilance Surveillance Assessor, the Scientific Officer post is located within the Human Products Monitoring (HPM) department working in the area of evaluation of pharmacovigilance data and contributing to Blood, Tissue & Cell and Organ (BTO) vigilance related activities, as necessary.
The role of the Scientific Officer is to contribute to the safety monitoring of medicines and BTO vigilance activities, to ensure HPRA obligations and requirements with regard to reporting are met in an appropriate and timely manner, to appropriately review, evaluate, follow up, collate and present adverse reaction data, to provide input and support for responses to technical and other queries, to support team organisation and activities to achieve required levels of performance and to respond effectively to changes in the internal and external environment.
The Scientific Officer is responsible for contribution to and development of the quality management system for the Pharmacovigilance (PV) section, liaising with the team as necessary. In this regard, the Scientific Officer works closely with colleagues in the PV team and as needed with colleagues, particularly in the wider HPM department, Compliance, Human Products Authorisation and Registration (HPAR), IT and Customer Service.
Key Responsibilities
Strategic Objectives:
- Working closely with the Pharmacovigilance Surveillance Assessor and other members of the team to ensure timely, effective and appropriate processing and evaluation of adverse reaction data, including follow up of individual case safety reports (ICSRs)
- Working with colleagues to facilitate changes to safety reporting requirements arising from revisions to clinical trials legislation
- Liaising with and providing technical information, advice and guidance on PV matters to HPRA and other regulatory colleagues, pharmaceutical companies, relevant national and international bodies, healthcare professionals and members of the public
- Working with colleagues to ensure that the strategic and operational goals of the PV section are achieved
- Attending and contributing to meetings, as necessary
For more information, please refer to the role profile below. Applications should be submitted via the HPRA Recruitment Portal
Role Profile Application form