On behalf of my client, I am recruiting for a GCP/Pharmacovigilance
Inspector.
The successful candidate will report to the GCP/Pharmacovigilance
Inspection manager, the role of the inspector is to evaluate the
compliance of sites inspected - both in Ireland and internationally,
with the requirements of both National legislation and European
regulations. The role involves inspecting, reporting and forming
conclusions in respect of the suitability of a site including GCP and
GVP standards.
Qualifications:
Minimum 3 years relevant experience working in a clinical trial or
pharmacovigilance environment
Knowledge of relevant European and national legislation and guidance
in relation to GCP and Pharmacovigilance
A valid full driving license and a vehicle
Expert knowledge of clinical study operations, preferably having had
responsibility for study/site management, data management or
regulatory affairs
Experience in performing regulatory inspections or industry audits
Experience in bioanalytical methods
Responsibilities:
Operational:
Preparing for, organising and carrying out inspections
Compiling inspection reports, and contributing to preparation of joint
reports
Working with the Inspection Manager to agree appropriate performance
related targets
Liaising with relevant departments of the HPRA to facilitate the
identification,
performance, evaluation and follow-up of inspection and compliance
activities
Assisting the managers in the inspection department
Assisting in the effective implementation of the organisation**Apply
on the website**;s Quality Management System within the Compliance
department
If you are interested in applying for this role, please call Ciara on
1 or email
Thornshaw Scientific Recruitment is a leading Irish provider of
specialist Scientific Recruitment. Part of the CPL Group. GCP/Pharmacovigilance Inspector
On behalf of my client, I am recruiting for a GCP/Pharmacovigilance
Inspector.
The successful candidate will report to the GCP/Pharmacovigilance
Inspection manager, the role of the inspector is to evaluate the
compliance of sites inspected - both in Ireland and internationally,
with the requirements of both National legislation and European
regulations. The role involves inspecting, reporting and forming
conclusions in respect of the suitability of a site including GCP and
GVP standards.
Qualifications:
Minimum 3 years relevant experience working in a clinical trial or
pharmacovigilance environment
Knowledge of relevant European and national legislation and guidance
in relation to GCP and Pharmacovigilance
A valid full driving license and a vehicle
Expert knowledge of clinical study operations, preferably having had
responsibility for study/site management, data management or
regulatory affairs
Experience in performing regulatory inspections or industry audits
Experience in bioanalytical methods
Responsibilities:
Operational:
Preparing for, organising and carrying out inspections
Compiling inspection reports, and contributing to preparation of joint
reports
Working with the Inspection Manager to agree appropriate performance
related targets
Liaising with relevant departments of the HPRA to facilitate the
identification,
performance, evaluation and follow-up of inspection and compliance
activities
Assisting the managers in the inspection department
Assisting in the effective implementation of the organisation**Apply
on the website**;s Quality Management System within the Compliance
department
If you are interested in applying for this role, please call Ciara on
1 or email
Thornshaw Scientific Recruitment is a leading Irish provider of
specialist Scientific Recruitment. Part of the CPL Group.
We need : English (Good)
Type: Permanent
Payment:
Category: Others