Closing date for applications: 09/03/2023
Role Summary
Reporting to the GCP/Pharmacovigilance Inspection Manager, the role of an Inspector is to evaluate the compliance of sites inspected, both in Ireland and internationally, with the requirements of national legislation (in Ireland), European community directives, regulations and guidance. These sites may include:
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Sites where clinical trials are conducted (e.g. hospitals, clinics, healthcare centres, clinical research facilities)
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Sites responsible for management, administration or data collection activities for clinical trials (e.g. sponsor organisations, clinical research organisations)
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Clinical trial testing laboratories, including bioanalytical facilities
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Sites where pharmacovigilance data is collected, evaluated or processed by, or on behalf of, marketing authorisation holders
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Marketing authorisation holders or affiliate offices
The Inspector provides technical information and advice to relevant individuals both internal and external to the HPRA and provides support to the enforcement and execution of national regulations in relation to human and veterinary medicinal products. The role involves inspecting, reporting and forming conclusions in respect of the suitability of a site for the activities which it has responsibility for. The key standards that apply include;
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Good Clinical Practice (GCP)
- Good Pharmacovigilance Practices (GVP)
Key Responsibilities
Operational
- Preparing for, organising and carrying out inspections in accordance with HPRA and Union procedures
- Evaluating complex information, identifying relevant standards and assessing compliance
- Compiling inspection reports when acting as lead inspector, contributing to preparation of reports for joint or accompanied inspections
- Assisting in the compilation of data and preparation of management reports as required
- Applying risk management principles
- Submitting reports as required and maintaining appropriate records of meetings and activities
- Ensuring a database of inspection details is maintained
- Assisting in the introduction of new legislation, and development of policy and practice guidelines and procedures
- Providing support to other areas of the HPRA, where appropriate
For more information, please refer to the role profile below. Applications should be submitted via the HPRA Recruitment Portal
Role Profile Application form