Skip to main content

This job has expired

GCP/Pharmacovigilance Inspector

Employer
Thornshaw Recruitment
Location
Dublin (County), Leinster (IE)
Salary
Negotiable
Start date
15 Sep 2022
Closing date
4 Oct 2022

View more

Job Details

On behalf of our client, we are currently recruiting for a GCP/Pharmacovigilance Inspector, Inspection – Compliance. This is a 3 year contract role. This is a hybrid role, based 3 days a week in Dublin City and 2 days remote. There is also travel involved, nationally and internationally.

 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:

  •  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 o 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 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;

  •    Good Clinical Practice (GCP)
  • Good Pharmacovigilance Practices (GVP) 

     KEY RESPONSIBILITIES

    • Preparing for, organising and carrying out inspections 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

     QUALIFICATIONS AND EXPERIENCE

    • To be considered for this post, candidates must have: 3rd level degree in a relevant scientific or related discipline such as medicine, pharmacy, pharmacology, toxicology or other fields relevant to the principles of good clinical practice A minimum of three years’ relevant work experience in a clinical trial or a pharmacovigilance environment. Whilst clinical trial experience is preferred, those with relevant experience in pharmacovigilance and transferrable skills relevant to GCP, and an ability to learn the principles and concepts of GCP are also encouraged to apply. Knowledge of relevant European and national legislation and guidance concerning GCP and pharmacovigilance. A proven ability to assess complex information and make effective decisions, in particular in a time dependent setting. o A valid full driving licence and vehicle. o Evidence of excellent communication and report writing skills. A proven ability to continuously learn and maintain awareness of evolving standards / requirements. Proven ability to work as part of a multi-disciplinary team. Availability to travel regularly for national and international inspections is a requirement in this role.  
    In addition to this the ideal candidate will have: Expert knowledge of clinical study operations, preferably having had responsibility for clinical trial management, site management or data management. o Experience in performing regulatory inspections or industry audits. o Experience in bioanalytical methods. Ability to be flexible, to prioritise and manage work load and to show initiative when required. A proven ability to react effectively to emerging work-related issues.

    For full details contact Linda at +353 1 2784701 or email your CV to ldunne@thornshaw.comThornshaw Scientific is a division of the CPL Group www.thornshaw.com

Company

thornshaw-title

Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment.  In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.

Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.

Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.

Our Industries

We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years. 

Our Specialities

Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.

Our Mission

thornshaw-ourmission

For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com

 

Company info
Website

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert