Overviewavance clinical is seeking a senior drug safety associate located in bengaluru. The role involves drug safety reporting and management services for assigned projects, ensuring the preparation or review of safety reporting plans (srp), collection, processing and reporting of safety events and other safety information in accordance with the csp, avance sops, ich gcp guidelines and applicable regulatory requirements.role titlesenior drug safety associatelocationbengaluruqualifications, skills and experienceordinary degree in an appropriate/related discipline.minimum of 8 years’ experience in a safety/pharmacovigilance role or relevant combination of pharmaceutical/cro industry experience and qualifications.minimum of 8-10 years’ experience in pharmaceutical industry/cro working in a gcp environment.formal and current ich gcp training.thorough knowledge of australian regulatory and ec clinical trial safety reporting requirements.sound knowledge of fda and ema regulatory and ec clinical trial safety reporting requirementssound knowledge of meddra and who drug coding.ability to communicate at a high level with clients, senior management and other stakeholders.core responsibilitiesconfiguration of study specific safety databases in accordance with avance sops.maintain a project specific safety database/dataset (where avance clinical holds the safety database).create, modify and/or review study specific srps as required per project in accordance with the csp and client/avance clinical contractual arrangements.prepare icsr reporting forms and completion guidelines for the investigational sites and liaise with the cpms and cras to ensure timely distribution of the approved forms and guidelines to the sites.participate in study kick-off meetings with study project staff as required.autonomously act as lead safety officer and maintain oversight on regulatory compliance and status of safety-related services for assigned projects.icsr processing – ensure timely reporting, tracking, filing and distribution of sae, eiu, susar, and/or other safety reports to applicable parties including regulatory authorities (ras), ethics committees (ecs), sponsors/clients and investigators.perform reconciliation of sae receipt and regulatory reporting with sponsors/clients as outlined in the srp.liaise with data management for reconciliation of information provided on sae reports with the study adverse event database and entering of single cases into the sae and eiu database where applicable.ensure up-to-date knowledge of applicable regulatory safety requirements on a per-project basis.what we offerstimulating workproject diversityan intellectual challengean agile & flexible workplaceopportunity to progressstabilitysense of communitya leadership team that are working together on a common goalflexible work optionsgreat tools / tech to do your joba competitive salary & an extra day’s holiday for your birthday
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