Closing date for applications: 02/06/2022
Role summary
Reporting to the Inspection Manager, the role of the Good Clinical Practice (GCP)/Pharmacovigilance (PV) Inspection Manager is to manage, develop and operate the HPRA GCP/PV inspection processes, to achieve required levels of performance and to respond effectively to changes in the internal and external environment.
In conjunction with the Inspection Manager, the GCP/PV Inspection Manager manages the overall performance of the GCP/PV Inspection team by defining objectives, setting targets, coordinating activities, agreeing priorities, developing team members, maintaining effective communication lines; and ensuring that the required standards, policies and practices are in place.
Key Responsibilities
Strategic Management
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The manager will be required tohave specialist knowledge that supports the assessment work of central marketing authorisation applicant (CMAA) Rapporteurs and Pharmacovigilance Risk Assessment Committee (PRAC) Rapporteurs, including the rolling reviews for COVID 19 vaccines and drive strategic initiatives both nationally and within the network.
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Develop structures to support the oversight of safety and GCP oversight required for the national coordination of Clinical Trial supervision under the clinical trial regulation (CTR) with the National Office for Research Ethics Committees.
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Support the Inspection Manager in the management and ongoing development of the GCP/PV inspection team
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Provide leadership, support and direction to the GCP/PV inspection team
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Provide input on the direction of the GCP/PV inspection team for inclusion into the annual business plan for the Compliance department
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Work to ensure that the strategic and operational goals set for GCP/PV and BE inspections are achieved
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Support the development and maintenance of integrated processes across the inspection teams to ensure the strategic and operational goals of the Compliance department are achieved
For more information please refer to the role profile below. Applications (Application form and CV) should be sent directly to our recruitment inbox jobs@hpra.ie
Role Profile Application form