GCP/Pharmacovigilance Inspector, Inspections – Compliance

Closing date for applications: 09/06/2019

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:

• Sites where clinical trials are conducted (e.g. hospitals, clinics, healthcare centres, clinical research facilities)
• Sites responsible for management, administration or data collection activities for clinical trials (e.g. sponsor organisations, clinical research organisations)
• Clinical trial testing laboratories, including bioanalytical facilities
• Sites where pharmacovigilance data is collected, evaluated or processed by, or on behalf of, marketing authorisation holders
• 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 standards that apply include;

• Good Clinical Practice (GCP)
• Good Vigilance Practice (GVP)

Role Profile       Application Form

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