Drug Safety Associate

Job Description

Job Purpose: The Drug Safety Associate I, will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). Responsible for processing of Individual Case Safety Reports (ICSRs) from various sources, Literature search and review, signal detection and management, tracking regulatory information, performing regulatory submissions and supporting preparation of aggregate and other study reports, as well as Medical and Product Dictionary Management activities, where applicable Responsible for ICSR compliance and related processes including but not limited to quality review of ICSRs, metrics generation and late case investigation in accordance with International and local regulatory reporting requirements, where applicable.Key Accountabilities:Accountability Supporting ActivitiesGeneral Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client s guidelines, and SOPs, and Global drug safety regulations Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting Assist in development of project specific safety procedures, workflows and templates Attend internal, drug safety and project specific training sessions Completes trainings assigned on internal and client Learning Management System (LMS) as applicable Preparation for, participation in, and follow up on audits and inspections Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits Delegate work as appropriate to Drug Safety Assistants Liaising and collaborating with the relevant function at the client s end to facilitate the delivery of high-quality work Identifies areas of concern and raising the issues with the manager Archiving the source documents and relevant emails as required Responds to clients/customers in a timely mannerCase processing Monitoring of incoming reports from various sources viz mailboxes, EudraVigilance, literature searches etc. Perform literature searches as per search strategy, performs data entry of valid cases into the safety database Triage of incoming reports for completeness, legibility and validity, including literature abstracts/articles/citations Responsible for sending translation requests, if any Perform a check on overall medical cohesiveness and consistency of the document Compares and analyses data provided by the affiliate with the data available on client application Prepares ADR form/coversheet as required Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool Creates the case on the safety database Performs clear and accurate data capture of cases in accordance with client conventions/guidelines and Standard Operating Procedures (SOPs) Ensures that the expectedness, causality assessment and seriousness criteria are accurate for the events Ensures MedDRA coding in accordance with MedDRA Term selection: Points to Consider Request follow-up and perform query management, as applicable Prepares medically cohesive case narratives based upon the reported information Routes the case to the next workflow state as applicable in the safety databaseQualificationsKnowledge and Experience: Related experience in drug safety/ pharmacovigilance is desirable especially literature review Good knowledge of medical terminology. Related experience gained in a healthcare environment is an advantage.Education: Degree in life Sciences, Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.). A degree in Medicine/Dentistry/physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage.,

Keyskills :
case processingpharmacovigilancesafetycasedata entryitem response theorystandard operating proceduresdrug safetymusic makinglife sciencesstudy reportssearch strategyquery managementsafety management