• Adjudication Coordinator I

    Job Location(s) IN-Bangalore
    Job Number
    Job Category
    Drug Safety/Pharmacovigilance
    Position Type
  • Job Overview

    Operate in accordance with the Adjudication Services Operational Plan in place on assigned project(s).

    - Perform processing of adjudication events. This includes, but is not limited to:

    • Maintaining event tracking systems.
    • Event case processing: intake and triage, event linking, event de-activation, tracking, data entry, document processing (e.g. redaction of specified content), review of incoming event information for completeness and accuracy, content review, identification of missing required data and or documents, generation of queries, query review and closure/re-issue.
    • Contacting site personnel to obtain missing data and/or documents.
    • Escalating open events for issue resolution and closure, in accordance with relevant Escalation Plan.
    • Completing First Review QC Checklists, assembling dossiers..
    • Conducting event reconciliation processes.
    • - Assist with implementation of adjudicator work-flows. This includes, but is not limited to:
    • Implementation of adjudicator disagreement resolution processes.
    • Implementation of re-review and re-adjudication processes.
    • Processing of adjudicator requests for additional documentation.
    • Processing of adjudicator notifications of potential un-reported events.- Assist with adjudication committee compilation processes. This includes, but is not limited to:
    • - Assist with preparation of event adjudication status reports and metrics.
    • Identification and screening of potential adjudicators.
    • Collection of signed Confidentiality Disclosure Agreements, CVs, completed Adjudicator Selection Questionnaires, signed Contracts from potential adjudicators.- Build and maintain good working relationships within Adjudication Services department and across functional units.
    • - Any other duties as assigned by management.
    • - Work in accordance with the Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs).


    • B.Sc/M.Sc Life Sciences or equivalent with 2+ years of relevant experience**


    Adjudication experience includes direct experience receiving and processing events for adjudication, working to collect event data and documents required for adjudication, working within adjudication event tracking systems.


    - High degree of accuracy with close attention to detail.

    - Functions as a strong team player.

    - Ability to work efficiently with moderate guidance.

    - Ability to effectively balance multiple concurrent priorities.

    - Strong written and verbal communication skills.

    - Basic knowledge of medical terminology desirable.

    - Basic familiarity with hospital documentation practices desirable.

    - Basic understanding of Good Clinical Practice (GCP).

    - Accurate math and spelling skills preferable with an aptitude for handling and proof-reading numerical data.

    - Good keyboard skills with knowledge of MS Office and Windows applications beneficial.


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