- Case Processing of ICSRs in Pharmacovigilance database.Entering source data in the database, Event Coding using MedDRA, Narrative(s) writing and Generate Follow-up letters.Review of literature articles and assessment for identifying valid ICSRs.Quality Check of ICSRs in databaseSupport in preparation of aggregate reportsSupport in Signal detection of the ADRs with cases received from client's products.Compliance to project guidelines… Show more - Case Processing of ICSRs in Pharmacovigilance database.Entering source data in the database, Event Coding using MedDRA, Narrative(s) writing and Generate Follow-up letters.Review of literature articles and assessment for identifying valid ICSRs.Quality Check of ICSRs in databaseSupport in preparation of aggregate reportsSupport in Signal detection of the ADRs with cases received from client's products.Compliance to project guidelines Execution of Company Standard Operating ProceduresBuilds and maintains good relationships across functional units and company affiliatesMaintain awareness of changes to/new regulations affecting PVG activitiesOther duties as assigned by management Show less

To create the cases from the inbox and to send to appropriate workflow after Duplicate Search. To review the peer’s work before the cases are pushed in SCEPTRE.Performing Triage and Selection and assessment of appropriate Adverse Events.Perform appropriate Data entry into Safety database and ensure adherence to SOPs.Validation of reportable case and maintain its auditable trace record.To Perform thorough Duplicate Search of cases.Carry compliance… Show more To create the cases from the inbox and to send to appropriate workflow after Duplicate Search. To review the peer’s work before the cases are pushed in SCEPTRE.Performing Triage and Selection and assessment of appropriate Adverse Events.Perform appropriate Data entry into Safety database and ensure adherence to SOPs.Validation of reportable case and maintain its auditable trace record.To Perform thorough Duplicate Search of cases.Carry compliance operations that govern regulatory requirementsCreate, maintain and assume accountability for a culture of high customer serviceTake responsibility for quality of data processed.To handle the queries and mails if any from vendors and Clients.Drug safety data management processes implementation: Call intake, Case intake, Case triage, Case data entry, Adverse Event Coding, Case follow-up. Show less