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Medical Reviewer

Newark Metro Area, NJ

Posted: 09/25/2018 Job Type: Clinical Job Number: JN -092018-22650
  • Medical Reviewer, Global Drug Safety & Risk Management
  • MD or MBBS required
    Two (2) years relevant medical experience minimum, post graduation
    Independent decision making and ability to influence required
    Excellent written and oral communication skills in English required
    Computer proficiency required, including database and MS Office Suite products
    Two (2) years pre- and post-marketing drug safety experience preferred
    Knowledge of medical aspects in drug safety preferred
    Working knowledge of MedDRA, WHO-DD is strongly preferred. Knowledge of clinical data management processes is preferred
    Knowledge of global PV regulations preferred
    Medical Reviewer, GDSRM provides medical advice, assessment and input to the activities of AE case management as well as contributes to global pharmacovigilance & trials activities through ensuring appropriate operational output and support and act as a significant point of contact between Global Drug Safety and Risk Management and Trial Safety Surveillance
    Responsibilities include, but are not limited to:
    Execute the medical review of individual case safety report (narrative, coding, labeling, independent company causality assessment, pharmacovigilance comment) and manage corrections with assessment as applicable
    Ensuring medical accuracy of all aspects of the Case Management group s output
    Ensuring internal escalation and communication of ICSRs to Lead Product Safety Physician for cases of special interest or SUSAR reports from clinical trials and generate discussions with relevant parties (Safety Science, Trials Safety Staff) if required
    confirm SUSARs and IND Safety Reports
    Manage unblinding of ICSRs from double blinded studies
    Create search criteria, generate report and prepare Analysis of Similar Events (AOSE)
    Contribute to solving reconciliation coding issues/discrepancies
    Review and update generated follow-up letters as appropriate
    Review daily line listing of serious cases and manage corrections with Assessment as applicable
    Communicate with Lead Medical Reviewer for cases of special interest or SUSAR reports from clinical trials and generate discussions with relevant parties (Safety Science, Trials Safety Staff) if required
    Present cases of interest to GDSRM peers during Safety Management Team/therapeutic area meetings as required.
    Contribute to the resolution of issues from cases of high complexity through medical expertise and team interactions
    Manage review of cases according to internal timelines
    Provide input to aggregate reports including PSURs as required
    Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates
    Participate in product review meetings.

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