Utkranti Aher

Background

About Utkranti Aher

PV Experience- Experienced to assure assessment of cases, perform end to end case processing activity including triage, data, review of different types of reports to ensure accuracy, integrity, completeness of safety information & to ensure consistency of medical coding, act as POC for pharmacovigilance case processing activity, data analysis, summaries including assisting in responding to queries from health authorities, clients- Supported product safety group with event of interest for the programs, assist with retrospective review and reconciliation of the cases. Supported pharmacovigilance acting team in developing drug safety and pharmacovigilance conventions- Analyzed safety data from completed PV cases, ensured timely completion and submission of drug safety report, maintained compliance with corporate policies, SOP's and global regulation- Evaluated events of special interest, participated in PV committee meetings on knowledge of drug safety, assisted in preparation of drug safety related sections and integrate case related information- Acted as POC for opinions on pharmacovigilance related matters, access, identified process gaps, conducted training sessions for identified flaws. Provided timely solution on the points of doubts. Given expert quality opinion on complex matters in timely manner- Tracked and identify cases in workflow i.e received/processed late per timelines, access and verify CAPA and regulatory affairs as applicable per sequence of action which lead to delaying of reports. CDM Experience: Experience in Clinical Data Management and Database design experience with hands on command in CRF, eCRF, safety data processing and aggregate reporting. Performed CDM activities from Start-up, Conduct and Closure stages. Proven skills in database development and database migration activities. Excellent knowledge of medical terminology and coding dictionaries (MedDRA and WHODD). Expertise in Microsoft Office suite. TOOLS/DATABASES USED CRM, Medidata Rave, Trial Master, ARIS G, Argus, Fusion and AG Xchange databases, Eclipse.