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    Drug Safety Associate

    Parexel
    Freshers years
    Not Disclosed
    Hyderabad
    10 March 11, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill

    Drug Safety Support:

    • Assist in development of project specific safety procedures, workflows and template
    • Assist in project specific safety database setup, development of data entry guidelines, and user acceptance testing
    • Triage incoming reports for completeness, legibility, and validity
    • Electronic documentation and quality control of drug safety information
    • Data entry of case reports into safety database / tracking system
    • Request follow-up and perform query management
    • Coding of data in the safety database
    • Writing case narratives
    • Create and maintain project specific working files, case report files and project central files
    • Assist with additional Drug Safety Specialist and/or Safety Service Project Leader (SSPL) activities as required
    • Inform Line Manager (LM)/Team Manager, Safety Services Project Leader (SSPL) or Project Leader (PL) and Regional Head of PV Operations of potential change-in-scope of projects
    • Support of Medical Directors/Safety Physicians, as needed, in medical monitoring activities
    • Participate in client and investigator meetings as required
    • Attend internal, drug safety and project specific training sessions
    • Perform literature searches
    • Preparation for, participation in, and follow up on audits and inspections
    • Delegate work as appropriate to Drug Safety Assistants
    • Assistance in development of Expedited Reporting Procedures
    • Assistance with registration with relevant authorities for electronic reporting on behalf of sponsor
    • Assistance with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
    • Submission of safety reports to investigators via ISIS (International Safety Information System)
    • Assist with measuring investigative site performance in conducting required tasks in ISIS
    • Tracking and filing of submission cases as required
    • Assist with unblinding of SUSARs, as required
    • Support collection and review of metrics for measuring reporting compliance

    Skills:

    • Analytical and problem-solving skills
    • Able to perform database/literature searches
    • Excellent interpersonal skills
    • Excellent verbal / written communication skills
    • Excellent organizational and prioritization skills
    • Ability to work collaboratively and effectively in a team environment
    • Client focused approach to work
    • Experience with computer applications


    Knowledge and Experience:

    • Related experience gained in a healthcare environment is an advantage


    Education:

    • Degree in Pharmacy, Nursing, Life Science or other health-related field, or equivalent qualification/work experience

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