SRAVANI JULURI

Pharmacovigilance Professional with 3.7+ years of experience in global safety case processing (clinical trials & post-marketing). Proficient in ArisG, LSMV reporting tools with proven expertise in ICSR data entry, medical coding (MedDRA, WHO-DD), duplicate search, query management, and quality control. Knowledge of ICH-GCP, GVP, and Schedule Y guidelines. Adept at signal detection, risk management support, and ensuring regulatory compliance while improving operational efficiency through process optimization.

• ICSR Case Processing (Spontaneous, Clinical Trial, Literature)
• Narrative Writing & Medical Coding (MedDRA, WHO-DD)
• Regulatory Compliance (ICH-GCP, GVP, FDA, EMA, Schedule Y)
• Pharmacovigilance Tools: ArisG, LSMV, Argus, Team Share
• Data Quality Control & CAPA Processes
• Query Resolution & Workflow Management
• Literature Screening & Safety Data Review, Signal Detection.

• Extensive knowledge of pharmacovigilance.
• Proficient in data entry on ICSR, triaging cases, duplicate checking, and booking in using Arisg/LSMV.
• Strong understanding of pharmacovigilance awareness, seriousness criteria, validation criteria, causality, various causality assessment methods, and adverse event reporting forms.
• Familiar with terminologies related to adverse events, ADE timelines, and active & passive surveillance systems.
• Knowledgeable about CEM, reporting types, narrative writing, Naranjo ADR Probability Scale, and Schedule Y.
• Well-versed in the CAPA (Corrective and Preventive Action) process.
• Knowledge on ICH-GCP, GVP guidelines and phases of clinical trials I, II, III, and IV.