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Details

Pharmacokinetics Assessor


Reference:AGBT-261057 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Pharmacologist, Pharmacovigilance

Pharmacokinetics Assessor
Our client, a large regulatory body are currently recruiting a Pharmacokinetics Assessor to join their team. The Pharmacokinetics 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.

Responsibilities
• The analysis and critical appraisal of pharmacological aspects of pre and post marketing application including dossiers for medicines, scientific advice applications and clinical trial applications, and the preparation of assessment reports
• The assessment includes but is not limited to pharmacokinetic aspects (PK), bioequivalence, pharmacodynamics (PD), drug/drug interactions, Population PK analysis and modelling
• Liaise with assessment teams in the assessment of the above mentioned applications
• Provide advice scientific committees (e.g. Pharmacokinetics working party, modelling and simulation working party) and to contribute to the peer review of scientific evaluation documents
• Provide PK/PD advice on behalf of the organisation to stakeholders such as investigators, sponsors, and others to ensure that any planned study/project results and conclusions are presented accurately and without bias
• Represent the organisation at relevant National and EU meetings, when required
• Maintain and enhance personal and technical competence by keeping abreast of new and developing PK/PD methods/guidelines and development activities
• Contribute to and assist in the delivery of teaching technical staff on clinical pharmacology
• Providing data analysis to support policy direction, and other functions as may be determined depending on the needs of the organisation
• Assist the Clinical Assessment Manager and other managers in the Clinical Assessment section in ensuring the accuracy of relevant data inputted in the computer databases and information systems of the organisation

Requirements
• Have a 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
• Work experience in applying pharmacokinetic methods in biomedical research, pharmaceutical or CRO industry or drug regulatory agency
• Experienced with ICH GCP, regulatory (e.g. EMA and FDA) guidelines o
• 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
• Proven ability to evaluate and provide insight into assessments on issues with pharmacokinetics and make effective decisions
• Experience and knowledge with statistical software packages such as WinNonlin, Adapt or nonlinear mixed effects modelling software (e.g. NONMEM)
• Demonstrate strong organisational skills, including the ability to prioritise workload
• Ability to work under pressure to tight timelines
• Good strategic ability (including problem solving, critical thinking skills and thinking)
• Excellent oral and written communication skills
• Ability to work as part of a cross-functional team
• Excellent attention to detail


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

Sinead Cullen | Tel: +353 (0) 1 507 9252