Reporting to the GCP/Pharmacovigilance Inspection Manager, the role of the GCP Inspector is to evaluate the compliance of sites inspected, in Ireland and abroad, with the requirements of National legislation (in Ireland), European Community Directives, Regulations and Guidance.
These sites may include:
·Sites where clinical trials are conducted
·Sites responsible for management, administration or data collection activities for clinical trials, (sponsor organisations, clinical research organisations)
·Clinical trial testing laboratories
·Clinical trial central review facilities
·Sites where pharmacovigilance data are collected and/or evaluated and/or processed by, or on behalf of, marketing authorisation holders
·Marketing authorisation holders in Ireland
·Manufacturers of investigational medicinal products
·Contract quality control laboratories
·Responsible for inspecting, reporting and forming conclusions in respect of the suitability of a site for the activities which it has sought or is already authorised for. The standards that apply include; Good Clinical Practice (GCP) and Good Vigilance Practice (GVP)
·Provide support for the co-ordination of recalls of all associated regulated products.
·Provide technical information and advice to relevant individuals and organisations both internal and external to the regulatory body.
·Provide support to the enforcement and execution of national regulations in relation to medicinal products, blood, tissues and cells.
·Prepare for, organising and carrying out inspections in accordance with domestic and European procedures
·Writing inspection reports when acting as lead inspector, contributing to preparation of reports for joint or accompanied inspections
·Assist in the compilation of data and preparation of management reports as required
·Apply risk management principles
·Submit reports as required and maintaining appropriate records of meetings and activities
·Ensure the database of inspections performed is maintained
·Assist in the development and implementation of policy and practice guidelines and procedures
·Providing support to other areas of the organisation where appropriate
·A degree qualification in a relevant scientific discipline
·Minimum of three years’ relevant work experience in a GCP environment (preferred) or pharmacovigilance
·Good knowledge of GCP and Pharmacovigilance requirements
·Full clean driving licence and car
·Ability to travel
·Experience in GCP auditing and /or clinical trial monitoring
For more information contact Sinéad Cullen on +353879500821 or email@example.com