Simmi Sahore's Linkedin Analytics

I have 8+ years of experience in Pharmacovigilance. Currently working as a safety scientist for signal detection and performing signal detection activities from various sources like spontaneous reporting, interventional studies, non-interventional studies, non-clinical studies, systematic reviews, meta-analyses and supporting processes of validation. Working on various tools like Spotfire, Commonwealth Vigilance Workbench (CVW) and carrying out review of alerts from different regulatory databases like Eudravigilance, FAERS based on EB05 score. Supporting the preparation of PBRER and DSR activities. Also have experience as a Subject Matter Expert for case processing including but not limited to expertise in management of Individual Case Safety Reports (ICSRs) of all case types (Spontaneous, clinical studies, solicited programs and literature articles) which include triage, registration, duplicate search, data entry, MedDRA coding and data validation of ICSRs, writing narratives for Clinical Study Reports. Have experience as a Literature reviewer as well with expertise in handling review of Literature articles for both Case processing as well as safety information and signal detection. Have also trained and mentored Drug Safety scientists.