Associate or Sr. Associate Pharmacokinetics @ Apotex Research Pvt. Ltd.
Job Summary:
Responsible to perform pharmacokinetics and statistical analysis of concentration time data and to generate and review the randomization schemes, as when required.
Job Accountabilities:
Perform feasibility exercise for new projects to conduct bioavailability and bioequivalence studies.
Conduct pharmacokinetic and statistical analysis of concentration-time data of bioequivalence studies in compliance with Standard Operating Procedures (SOPs).
Perform work in compliance with regulatory guidelines and SOPs.
Prepare and review the pharmacokinetic/statistical section of Bio-study Reports in accordance with different regulatory guidance (e.g. FDA, TPD and EMEA etc.).
Assist in development and revision of SOPs.
Prepare comprehensive summaries of pharmacology/toxicology information and other document necessary for regulatory submission.
Generate/review randomization schemes.
Prepare/review 100% snapshot data
Prepare regulatory updates for DCGI submission
Prepare/review FDA tables for US submission & CSBE document for CDN submission
Prepare justification for queries from regulatory agencies
Estimate LOQ and sample size for the study
Evaluate mathematical model for an analytical standard curve.
Utilize knowledge and understanding of pharmacokinetics, pharmacology and statistics to provide scientific advice and support to other departments.
Maintain, update and archive study related files and documents.
Execute other duties as assigned by management and as training and experience allow.
Click here to apply
Job Summary:
Responsible to perform pharmacokinetics and statistical analysis of concentration time data and to generate and review the randomization schemes, as when required.
Job Accountabilities:
Perform feasibility exercise for new projects to conduct bioavailability and bioequivalence studies.
Conduct pharmacokinetic and statistical analysis of concentration-time data of bioequivalence studies in compliance with Standard Operating Procedures (SOPs).
Perform work in compliance with regulatory guidelines and SOPs.
Prepare and review the pharmacokinetic/statistical section of Bio-study Reports in accordance with different regulatory guidance (e.g. FDA, TPD and EMEA etc.).
Assist in development and revision of SOPs.
Prepare comprehensive summaries of pharmacology/toxicology information and other document necessary for regulatory submission.
Generate/review randomization schemes.
Prepare/review 100% snapshot data
Prepare regulatory updates for DCGI submission
Prepare/review FDA tables for US submission & CSBE document for CDN submission
Prepare justification for queries from regulatory agencies
Estimate LOQ and sample size for the study
Evaluate mathematical model for an analytical standard curve.
Utilize knowledge and understanding of pharmacokinetics, pharmacology and statistics to provide scientific advice and support to other departments.
Maintain, update and archive study related files and documents.
Execute other duties as assigned by management and as training and experience allow.
Click here to apply
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