Drug Safety Associate @ Maatrom Solution

Job Description

Job description

    Analyzes, reviews, and interprets safety data, both non-clinical and clinical, literature and any other relevant sources
    Responsible for performing end to end case processing of Individual case safety reports to meet regulatory timelines
    Perform initial evaluation of spontaneously reported adverse events including reports from post marketing surveillance studies
    Responsible for identifying duplicate/invalid ICSRs
    Perform case processing from clinical trial, literature, spontaneous, market research, social media and solicited cases for both serious and non-serious reports
    Perform data entry for all subject information into EDC databases as required
    Perform peer review, quality review of cases as and when required
    Perform peer review, quality review of all EDC data entered as required
    Accountable for sending queries for clarity associated with incoming information if required
    Ensure accurate and consistent coding of all the events, drugs /procedures/indications and laboratory tests according to the appropriate dictionary (For e.g., Company Product Dictionary, WHO-DD).
    Ensure that case narrative comprises correct and appropriate safety information
    Ensure that all the cases being processed with quality and submitted in a timely manner without any delays according to the service level agreement.
    Contributes to safety and pharmacovigilance training programs.
    Collaborates with Regulatory Affairs to ensure appropriate reporting of pharmacovigilance and drug safety information to regulatory agencies and prescriber community.
    Serves as a subject matter expert for vendors providing drug safety and pharmacovigilance services.
    Training and mentoring of Pharmacovigilance Associates


EDUCATION AND EXPERIENCE REQUIRED:

    Minimum 1+ year of experience in drug safety or clinical research domain
    Degree in Life Science/Pharma or Equivalents

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Keyskills:   pharmaceutical medicine pharmaceutical care medical affairs clinical research experience drug regulatory affairs drug safety pharmacovigilance interpersonal skills