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Details

Pharmacovigilance Inspector


Reference:KS/ARSJ-188352 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed

Our client is a leading regulatory authority based in Dublin. They are seeking a Pharmacovigilance Inspector to join an established team on a 2 year contract. 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.
The Inspector provides technical information and advice to relevant individuals both internal and external to the our client 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;
o Good Clinical Practice (GCP)
o Good Vigilance Practice (GVP)

Role/Responsibilities:
- Operational
o Preparing for, organising and carrying out inspections in accordance with our clients procedures
o Evaluating complex information, identifying relevant standards and assessing compliance
o Compiling inspection reports when acting as lead inspector, contributing to preparation of reports for joint or accompanied inspections
o Assisting in the compilation of data and preparation of management reports as required
o Applying risk management principles
o Submitting reports as required and maintaining appropriate records of meetings and activities
o Ensuring a database of inspection details is maintained
o Assisting in the introduction of new legislation, and development of policy and practice guidelines and procedures
o Providing support to other areas of the clients departments, where appropriate
- Quality and Knowledge Management
o Assisting in the effective implementation of our clients Quality Management System within the Compliance department
o Assisting the managers in the Inspections section to ensure that there are effective mechanisms in place to capture, store and communicate information, experience and knowledge gained
o Assisting the managers in the Inspections section to ensure that available information and knowledge is shared & is effectively used by the Inspection section
o Assisting the managers in the Inspections section to ensure that inspection procedures remain up to date with relevant developments in National, European and international regulations, legislation and guides
- Performance Management
o Participating in the performance development programme (PDP) within the Inspections section to maximise efficiency gains for the Compliance department
o Working with the Inspection Manager to agree appropriate performance related targets
o Taking measures to identify and resolve issues impacting performance
o Reporting regularly on progress against specified objectives, goals and performance targets
o Effectively communicating objectives, goals and performance targets within the team
o Promoting a positive, open, friendly and professional working environment
- Communication/Customer Focus
o Attending and contributing to meetings of the Compliance department as required
o Liaising with relevant departments of our clients to facilitate the identification, performance, evaluation and follow-up of inspection and compliance activities
o Contributing by participating, as required, at national and international seminars in the areas of GCP and pharmacovigilance inspections
o Representing our client, as required, at national, European and international regulatory meetings and seminars
o Responding to queries (technical and procedural) from internal and external customers

Qualifications/Experience:
- To be considered for this post, candidates must have:
o A 3rd level degree in a life science, clinical or pharmacy discipline
o A minimum of three years’ relevant work experience in a clinical trial (preferred) or a pharmacovigilance environment
o Sound knowledge of relevant European and national legislation and guidance concerning GCP and GVP
o A proven ability to assess complex information and make effective decisions
o A valid full driving licence and vehicle
o Evidence of excellent communication and report writing skills
o Good computer skills
o Proven ability to work as part of a multi-disciplinary team
- In addition to this the ideal candidate will have:
o Expert knowledge of clinical study operations, preferably having had responsibility for study/site management, data management or regulatory affairs
o Experience in performing regulatory inspections or industry audits
o Experience in bioanalytical methods
o Ability to be flexible, to prioritise and manage work load and to show initiative when required
o A proven ability to react effectively to emerging work-related issues
o A proven ability to communicate effectively
o A proven ability to work unsupervised
o Availability to travel regularly for national and international inspections is a requirement in this role

For a more detailed job description & meeting to discuss the role in further detail please contact me at: Karen – 087 7452487 or send CV in confidence to karen.shiel@lifescience.ie

If you would like further Information you can contact the recruiter directly:

Karen Shiel | Tel: +353 (0) 1 5079256