Medical Review Scientist - Hyderabad / Secunderabad, Telangana - Amgen Technology Private Limited

    Amgen Technology Private Limited
    Amgen Technology Private Limited Hyderabad / Secunderabad, Telangana

    6 days ago

    Full time
    Description
    • To support global individual case safety reports regulatory reporting compliance
    • To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT)
    • To implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports
    • To act as a significant point of contact for Case Management on medical content of ICSRs
    • Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports
    • Support MSRT product lead if assigned
    • Execute ICSR case escalation as appropriate
    • Execute appropriate case follow up per SOPs
    • Support medical coding conventions, and systematic process improvements for ICSR medical review
    • Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems.
    • Support MSRT Product Lead activities for the list of expected terms in the auto label tool
    • Support Quality Assurance of ICSR medical review (if applicable)
    • Support training to vendor staff (if applicable) on ICSR medical review
    • Mentor junior medical reviewers.
    • Participate in Safety Assessment Team (SAT) (if applicable)
    • Provide input on teams for interdepartmental and cross-functional initiatives including process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review
    • Perform other duties related to the position as necessary as defined in SOPs or as requested by his/her supervisor

    Inspection Readiness:

    • Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
    • Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility

    What we expect of you

    • We are all different, yet we all use our unique contributions to serve patients.

    Basic Qualifications:

    • MD/DO or international equivalent AND
    • 3 years of related drug safety experience
    • Knowledge of Amgen Medical review and case management SOPs and regulatory requirements for pharmacovigilance
    • Clinical knowledge of therapeutic area patient populations and drug class
    • Proficiency in technical safety systems including the Amgen Safety database and medical coding
    • Knowledge of safety data capture in clinical trials and in the post marketing environments
    • Knowledge of clinical trials and drug development
    • Knowledge of Amgen products and patient population (preferred)

    Preferred Qualifications:

    • MD/DO or international equivalent AND
    • 4 years relevant work

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