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Job Details

Pharmacokinetics Assessor

Company: Thornshaw Recruitment
Location:
Reference: TD9709
Closing Date: 18 May 18
Type: Permanent
Salary (£): On Application
Benefits:

Job Summary:

Actively recruiting on behalf of my client for a Pharmacokinetics Assessor.   This is a new role to the organisation.

Requirements:

Actively recruiting on behalf of my client for a Pharmacokinetics Assessor.   This is a new role to the organisation.

Role & Responsibilities:
The Pharmacokinetics Assessor will use their scientific and professional expertise to assess the pharmacokinetic aspects of clinical trial data for marketing authorisation applications, preparing reports and recommendations, interacting with medical colleagues and multi-disciplinary advisory committees and company representatives as required. 
Your role will support the Clinical Assessment Manager and other managers in the Clinical Assessment section. 
Working with the Clinical Assessment Manager and other managers in the Clinical Assessment section in the preparation of work objectives for the section 
Operational Objectives 
Working with the Clinical Assessment Manager to plan and organise work tasks that ensure efficient delivery of work.
Assisting in the compilation of data and preparation of reports as required.
Attending meetings of the Advisory Committees as required.
Attending Working Groups/Committees/meetings at the European Medicine Agency (EMA), as required 
Assist the managers of the Clinical Assessment section to ensure the effective implementation of the Quality Management System within the section 
Assist the managers of the Clinical Assessment section to ensure that there are effective mechanisms in place to capture, store and communicate key information, experience and knowledge gained by the section 
Qualifications & Experience:
PhD in relevant pharmaceutical science with significant experience and thorough understanding of pharmacokinetic theory. 
Knowledge and experience of drug development (clinical and post-approval) and understanding drug development as a continuum. 
Experienced with ICH GCP, regulatory (e.g. EMA and FDA) guidelines 
Sound understanding of a wide range of pharmacokinetics (PK) and pharmacodynamics (PD) principles, including the most up-to-date techniques available that are relevant to the regulation of medicines, as employed across the breadth of the drug development process.
Significant experience in analysis methods, estimation methods and good modelling practices. 
The ability to critically analyse clinical/scientific information, make sound judgments on its value and write informative reports for a multi-disciplinary readership.

Experience and knowledge with statistical software packages  such as WinNonlin, Adapt or nonlinear mixed effects modelling software (e.g. NONMEM)
Please email your CV to tdunne@thornshaw.com or call Tina at +353 1 2784671.  Log on to www.thornshaw.com 
Thornshaw is a division of the CPL group

Apply for this job: Pharmacokinetics Assessor

Contact Information:

Address:  Head Office
Barton House 6 Old Dublin Road Stillorgan Co. Dublin

Rep. Ireland
Tel:  00 353 (1) 278 4671
Fax:  00 353 (1) 278 4672
Website:  Visit Our Web Site

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