Shifali S. - 18510 Regulatory Affairs Associate from Brampton

Drug safety associate II with over 4.5 years of experience in Pharmacovigilance operations, regulatory and medical affairs. Trained in management of Individual Case Safety Reports (ICSRs) involving international clinical trials Phase I to Phase III, Medical devices, Literature articles, Patient support programs, Post marketing surveillance studies, E2B, Health authority cases, Courtesy and social media, Market research studies and performing triage, registration/initiation of ICSRs into safety database, conducting duplicate search, data entry, narrative writing, MedDRA coding and data validation of ICSRs. Working knowledge of international drug safety regulations and guideline, including ICH (International council of harmonization) & FDA (food and drug administration) guidelines, Health Canada guidelines, CIOMS, EU PV legislations, and awareness of global regulatory reporting obligations.