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Pharmacokineticist II

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Título Oferta:
Pharmacokineticist II
Companhia:
by dejobs.org
Estado:
Sao Paulo SP
Texto Oferta:
**Job Overview:** **Your duties will include but not be restricted to:** + Fulfill the role of a study Pharmacokineticist. + Responsible for PK(/PD) deliverables within assigned projects. + Review draft protocols for allocated studies to ensure they meet the Sponsors requirements in terms of PK(/PD) analysis and study objectives. + Responsible for development of PK(/PD) Analysis Plans, to include methodology, definition of derived variables, and data-handling rules. + Conduct or review/QC interim PK(/PD) analyses, interpret the data, and attend dose escalation teleconferences to support dose progression in allocated studies. + Conduct or review/QC non-compartmental PK and PD analyses as specified in the report and analysis plans. + Conduct modeling/simulation of PK, PD, and PK/PD data and provide interpretation of the results. + Responsible for PK(/PD) input to reports including Clinical Study Reports. + Independent peer review of PK and PD deliverables (e.g., protocols, Analysis Plans, PK reports, Clinical Study Reports). + Carry out all activities according to appropriate Covance SOPs, working within the framework of the Quality Management System and to GCP. + Contribute to review and amendment of departmental processes and supporting documentation. + Provide PK input into other disciplines’ activities and participate in interdepartmental processes. + Represent Pharmacokinetics in internal and external audits. + Contribute to proposal activities and client presentations. **Education/Qualifications:** Bachelor’s degree in a Bioanalytical Chemistry or a Biological Life Sciences degree **Experience:** + Typically, a minimum of 3 years of experience in clinical pharmacokinetic and/or pharmacodynamic analysis. + Good knowledge of non-compartmental pharmacokinetic analysis, drug metabolism, andphysiological processes
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