Adduri Sruthi

Experience

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  Vigilare Biopharma Pvt Ltd

  Sept 2023 - now

  Knowledge on handling cases using safety databases (Oracle Argus safety database).Knowledge on processing of literature, spontaneous and regulatory authority cases.To perform duplicate search, triage and book in of received safety information.Preparation of minutes of meeting accordingly. Assist in training, mentoring of other associates as necessary and other project management activities.Expertise in QC for literature and other cases by checking proper event and drug coding in accordance with ICH and GCP guidelines.Primary responsibilities:To perform individual case safety report.To route processed ICSR to next workflow.To perform medical coding using MedDRA, drugs coding using CPD and WHO DD coding in accordance with ICH and GCP guidelines.To perform comprehensive narrative writing and case data entry according to standard operating procedures.Ensuring quality check of processed ICSR and reporting.Secondary responsibilities:Performing duplicate search and identification of duplicate cases and data base searches as necessary.Performing data entry of ICSR’s ensuring in compliance with client standard operating procedures and work instructions.Peer review, quality review of processed ICSR and overall regulatory compliance of assigned ICSR.Actively communicating with client on regular bases by mails or telecom for any claudication’s required.A highly skilled candidate who’s also communicative, instantly likeable and equally skilled.Having good adaptability and multitasking skills and working Soft skills: under pressure within predefined timelines. Show less

  • Drug Safety Associate

    Sept 2023 - now

  • Drug Safety Associate

    Sept 2023 - now