Prashant Warade Email & Phone Number

I am having 7 year of work experience in pharmacovilance , drug safety associate, as case processor and case triaging at Tata consultancy services.An experienced PV associate with 7 years of experience in Pharmacovigilance including Medical writing in signal management mainly in signal detection and preparation of signal draft reports, preparation of summary tabulation, Literature search and Regulatory screening as per GVP module 9 and client requirement. Case processing including data entry, peer review and training to freshers of individual case safety reports ((CSRs). Experienced in different types of ICSR reports including Literature, Spontaneous, MLM, regulatory reports. Familiar with international regulatory submissions guidelines of expedited cases for USFDA, EMA, Health Canada, TGA and CDSCO.Role and responsibilities: ICSR, PSUR, PEBRER handling Knowledge of regulatory timelines. Performing MeDRA coding assessment. Assessing causality for safety case reports. Perform expectedness and listedness assessment and ICSR report ability. Generate follow-up questionnaire for the cases. Case triaging and case booking as per source document. Distribution of ICSR for submission when required. Respond to queries from clients as required. Perform document management, including scanning and filling of source document. Assessed labeling of serious adverse events originating from spontaneous, clinical sources with reference to IB, CCDS. Ensured Confidential coding Hands-on expertise in end-to-end Case Processing in Pharmacovigilance database ARGUS.  Assisted in upgrading or downgrading of case, where applicable based on the medical assessment and seriousness criteria. Quality Check of Confidential which included review of source documents and ensuring that the case is accurate, correct and complete. Maintained a good working knowledge of the AE safety profile of assigned drugs, reference Safety Information documents, data entry conventions and guidelines, clients' procedures and international drug safety regulations.As a Case Processor: Full data entry of individual case safety reports into the safety data base (Argus). Assessment of seriousness, causality and Listedness for all cases. Process all incoming cases on Priority in order to meet Regulatory timelines. As Narrative writer– Generates concise, accurate and well-written case narratives which involved all relevant information of the case.