Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.
Post : Associate - Pharmacokinetics
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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