Career for M.Pharm to work as Pharmacokinetics Associate at Apotex
Post : Associate - Pharmacokinetics
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Job Responsibilities
- Conduct pharmacokinetic and statistical analysis of concentration-time data of bioequivalence studies in compliance with Standard Operating Procedures (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.).
- Prepare comprehensive summaries of pharmacology/toxicology information and other document necessary for regulatory submission.
- Preparation of Protocol Synopsis.
- Prepare/review 100% snapshot data.
- Generation/reviewing of randomization schemes.
- Prepare/review FDA tables for US submission and CSBE document for CDN submission
- Evaluate mathematical model for an analytical standard curve
- Development and validate of in-house SAS programs in line with the quality standards and regulations.
- Assist in study feasibility exercise for new projects to conduct bioavailability and bioequivalence studies.
- Review of the external CRO protocol and reports.
- Creating SDTM and AdaM datasets for the studies conducted by Apotex using CDISC package for regulatory submission.
- Prepare regulatory updates and sample size justification for DCGI submission
- Creation of master document in Training Master Database (TMA) Application and ensuring timely creation and closure of training sessions.
- EP locking, deviation and investigation reports and file notes tracking
- Maintain, update and archive study related files and documents.
- Works as a member of a team to achieve all out6comes.
- Evaluation of the new software for the PK analysis
- Performs all work in support of our Corporate Values of Collaboration, courage, perseverance and passion; Demonstrates strong and visible support of our values.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
Candidate Profile
M. Pharmacy with 2+ years of experience
Previous experience in the area of bioequivalence is an asset.
Expertise in area of pharmacokinetics, pharmacology and physiology.
Additional Information:
Experience: 2+ years
Location: Bangalore, KA
Education: M.Pharm
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Pharmacokinetics
End date : 10th May, 2018
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