•Hands-on experience in generating analysis datasets/sdtm/adam.•Extensive knowledge of the Discovery and Drug Development Process from protocol through FDA submission in clinical trial process phases I-IV. •Knowledge about ICH-GCP(E6) Guidelines, and principles of ICH GCP, proficiency in understanding study protocols, CRFs (Case Report Forms), and CDISC guidelines.•Knowledge of SDTM implementation guide. •Knowledge About SAS Tools -… Show more •Hands-on experience in generating analysis datasets/sdtm/adam.•Extensive knowledge of the Discovery and Drug Development Process from protocol through FDA submission in clinical trial process phases I-IV. •Knowledge about ICH-GCP(E6) Guidelines, and principles of ICH GCP, proficiency in understanding study protocols, CRFs (Case Report Forms), and CDISC guidelines.•Knowledge of SDTM implementation guide. •Knowledge About SAS Tools - SAS/BASE|SAS/SQL|SAS/ODS|SAS/GRAPHS. •Hands-on experience in using SAS Functions, and SAS options.•Knowledge about procedures like- proc print, proc content, proc sort, proc report, proc means, proc freq, proc format, proc transpose,etc... Show less

• Execute drug safety management processes- Case intake, Triage, Case entry, Medical coding and Validity assessment. • Assume responsibility of quality of data processed. • Identify and select the cases from a workflow, determine appropriate prioritization criteria and submission dates. • Types of cases handled- Serious and Non-serious Clinical trial, LSIT, and Spontaneous cases. • Evaluate adverse event report, assesses seriousness, latest received date and other… Show more • Execute drug safety management processes- Case intake, Triage, Case entry, Medical coding and Validity assessment. • Assume responsibility of quality of data processed. • Identify and select the cases from a workflow, determine appropriate prioritization criteria and submission dates. • Types of cases handled- Serious and Non-serious Clinical trial, LSIT, and Spontaneous cases. • Evaluate adverse event report, assesses seriousness, latest received date and other factor such as potential unusual failure in efficiency in order to prioritize workload to ensure compliance to establish timelines. • Generate using queries and argus interface and clarification, resolving and forwarding to next workflow and communicated to outside sources. Consistently used ARGUS features such as action items, contact log and work list for communication and for the follow-up requests. • Prioritized workload for assign products and liaises with other safety and compliance associates to ensure timely processing. Show less