Scientist, Qpp

Job Category Quantitative Pharmacology Pharmacometrics Summary of Job Responsibilities Reads and understands the Clinical Study Protocols Cytel Work Request Documents and Project Requirements Prepares and reviews Pharmacokinetic Analysis Plan PKAP using Clinical Study Protocols and Study Specifications Performs Integral data management data cleaning process and integration with Phoenix WinNonlin software PK PD analysis using Phoenix WinNonlin 8 1 or higher software in accordance with study specifications Plays an active role in planning execution and delivery of pharmacokinetic assignments ensuring on-time quality deliveries Creates Tables Listings and Figures TLFs and summary reports for regulatory submission Perform quality control and quality assurance of PK deliverables as per the client assignment specifications Should be proactive to pursue advanced technological aspects and mentor the team members in various technical and strategic aspects to meet the organization objectives Co-ordinates with the Client POCs for clarity of specifications data issues reviews schedules etc Co-ordinates cross-functional activities involving statisticians SAS programmers and medical writers involved in pharmacokinetic projects Reads and thoroughly understands applicable compliance standards such as GCP 21CFR11 ISO 17799 and client s SOPs Qualifications Minimum Education Master of Pharmacy M Pharmacy in Pharmacology Pharmaceutics Pharmaceutical technology Minimum Work Requirements 4-6 years of hands-on experience in PK PD analysis interpretation and reporting of clinical trials data using Phoenix WinNonlin software Should have profound knowledge in biopharmaceutics pharmacology clinical research pharmacokinetics and pharmacodynamic PK PD concepts Should be proficient in the concepts of Clinical Trials Good Clinical Practices GCP SOPs and regulatory specifications Should have good academic credits and excellent communication skills oral and written Skills Expertise in Phoenix WinNonlin software in creating workflows independently Demonstrated strong understanding of Drug Discovery and Development PK PD principles physiology pharmacology and biopharmaceutics through scientific presentations posters and publications Proficiency in Medical and Scientific writing Proficient in using GraphPad Prism R Programming and SAS software Thorough knowledge regarding International Conference on Harmonisation-Good Clinical Practice Basic Knowledge regarding Clinical Trials Methodologies