A healthcare professional with over 3 years of experience in pharmacovigilance domain and pursuing internship as clinical trial data analytics with great education institution of Kitel-AI. My education background (Bachelor’s of Pharmacy) and knowledge, experience of PV give me additional benefit in understanding clinical trial process and source documents.
Technical Project Experience
- Generation of DM (demographic) dataset of SDTM
- Generation of ADLB dataset of ADaM
- Validation of ADaM datasets using proc compare procedure
- Case report form annotation
- Report Generation: Created demographic table and generate the adverse event summary report classified by MedDRA system organ class by writing independent code in SAS using analysis datasets for demography and adverse event
- Generation of Advanced report generation 1: Generated the ‘Summary of Physical examination (Safety Analysis Set)’ report by writing independent code in SAS.
- Generation of Advance report generation 2: Generated the ‘Summary of Medical / Surgical History (Enrolled Population set)’ report by writing independent code in SAS.
Global Certifications (if any)
B. Pharm graduate of batch 2019 from Mumbai University with overall CGPA of 8.56
Work & Experience
Certified Base SAS programmer with knowledge and skills to write SAS program. I have acquainted myself with important SAS procedures such as proc means, proc freq, proc univariate, proc import, proc export, proc sort, proc transpose, proc gchart, proc compare, etc. I know how to merge datasets after sorting them, to select variables and observation as per specifications, and also I am well aware of SAS functions, format, informat, and data type conversion. As of now I have completed projects namely: CRF annotation, DM creation (SDTM), ADLB creation, report generation, and report validation. I have gained knowledge on data visualization as well using Power BI.
Processing ICSRs received from literature source, Health Canada and other spontaneous sources into the data base (ArisG). To perform relevant coding, draft medical narrative, and raise follow up to Authors/reporter to get more information of patient's condition, product information and event status.
Case processing of the cases received from solicited or non-solicited sources To perform second line review of cases for accuracy and quality To generate PR data daily which enlists the errors in the cases present in QR WF so that errors can be correct and overall project quality could be improved.
To write medical draft of the cases received from US law firm which was specific to motor vehicle accidents so that these drafts can be used by plaintiff to claim insurance To code the diagnosis using ICD-10 dictionary To perform the medical research of the diagnosis and include them in medical draft so that it can give an insight of seriousness of the condition.