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    Drug Safety Associate-Ii

    Parexel
    Minimum 2 years years
    upto 7.5 LPA
    Mohali
    20 July 11, 2024
    Job Description
    Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D, Nursing Skills: Causality Assessment, Communication Skills, GCP guidelines, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Drug Safety Associate-II

     

    Company Name: Parexel

    Locations

    • India-Mohali

    Time Type

    • Full time

    Posted On

    • Posted Today

    Job Requisition ID

    • R0000023755

     

    Job Description:

    Key Accountabilities:

    Drug Safety Support

    • Assist in the development of project-specific safety procedures, workflows, and templates.
    • Assist in project-specific safety database setup, development of data entry guidelines, and user acceptance testing.
    • Triage incoming reports for completeness, legibility, and validity.
    • Perform 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.
    • Write 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 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.
    • Assist in the development of Expedited Reporting Procedures.
    • Assist with registration with relevant authorities for electronic reporting on behalf of sponsor.
    • Assist with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy).
    • Submit safety reports to investigators via ISIS (International Safety Information System).
    • Assist with measuring investigative site performance in conducting required tasks in ISIS.
    • Track and file 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.
    • Ability 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

    • Minimum 2 years experience in ICSR case processing.

     

    Education

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

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