• PMS Specialist

    Requisition ID
    2018-5708
    # of Openings
    1
    Job Location(s)
    N/A 31 China
    Travel
    Less than 10%
    Education
    Bachelor's Degree
    Position Type
    Full Time
    Category
    Quality
  • Overview

    • Execute Medical Device post market Adverse event report and Advertisement submittion per CFDA Regulation.

    Responsibilities

    • Ensure that corporate and local procedures are followed.
    • Coordinate AE reporting process with CA and on-time report both domestic and worldwide Adverse Event according to CFDA regulation.
    • Coordinate Advertisement review process with Market, divisions, Compliance, driving advertisement submitting and compliance to regulation. Achieve related performance metrics.
    • Coordinate the AE investigation with Cook Manufacturers, follow up case investigation and on time close AE case in CFDA ADR system.
    • Participate in internal and external audit.
    • Have a sound understanding of, and comply with, the COOK Code of Conduct and Company Compliance requirements  
    •  

    Qualifications

    • Relevant college/university degree is essential.
    • Basic Statically analysis skill
    • Fluent English both in writing and oral

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