Covance

  • Assoc Medical Dir

    Job Location(s) CN-Shanghai | CN-Dalian | CN-Beijing
    Job Number
    2019-36413
    Job Category
    Physicians
    Position Type
    Full-Time
  • Job Overview

    • Responsible for medical review of serious adverse events arising in clinical trials.
    • Assumes responsibility for safety monitoring on assigned projects
    • Responsible for preparation and medical review of Aggregate Reports (Periodic Safety Update Reports – PSURs, Periodic Adverse Drug Experience Reports – PADERs) required by global regulatory agencies for review of safety information for assigned products, when authorized to perform this function on behalf of a client.
    • Provides pharmacovigilance support to project physicians, as appropriate.
    • Provides medical/safety expertise to project teams, including communicating information regarding drug safety regulations and any changes that have occurred
    • Participates in training opportunities to advance knowledge of pharmacovigilance as it relates to drug/product development and drug/product marketing utilizing good clinical practice guidelines
    • Responsbile for medical review of serious and nonserious adverse events from spontaneous reports and reports derived from regulatory authorities and the medical literature during postmarketing surveillance when authorized to perform this function on behalf of a client.
    • Responsible for signal detection and evaluation activities and preparation and submission of Ad Hoc Reports reviewing specific safety issues to the global regulatory agencies for assigned products, when authorized to perform this function on behalf of a client.

    Education/Qualifications

    Required:

    • MD or DO with at least one year of postgraduate training or equivalent.
    • English at ILR level 4 or higher

     

    Preferred:

     MD who has completed an accredited residency program or equivalent and is board-eligible or certified

     

    Experience

    Required:

    At least 2 years of experience working either for a pharmaceutical company, health authority or a contract research organization in Drug Safety or related fields such as QA, Regulatory Affairs, medical writing, PCS, TM or clinical medical monitoring

     

    Preferred:

    At least 4 years experience working either for a pharmaceutical company, health authority or a contract research organization with substantial knowledge of drug safety and the global regulations governing pharmacovigilance and risk management

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