Valeant Pharmaceuticals

  • Specialist Engineer EU MDR, Global Device Complaints Management

    Job Location US-NJ-Bridgewater
    Job ID
    10506
    Pos. Category
    Quality
    Pos. Type
    Full Time
  • Overview

    Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

     

    Primary responsibility is to support the global reporting obligations and the management of communication between Valeant company affiliates, distributors and competent authorities for all medical device complaint related activities, including assistance of and/or submission of medical device event reports in accordance with applicable local laws and regulations.

     

    The scope of this position is directly related to Post Market Surveillance for all company medical devices as assigned.

    Responsibilities

    • Produce periodic PMS Reports by product family and support the generation and update of PMS plans.
    • Perform periodic trend analysis as a PMS early warning system on complaint data.
    • Perform Post Market Surveillance trend analyses. Generate or apply statistical methods with appropriate risk-based justification.
    • Lead or support of PMS related projects to improve source data required for PMS activities.
    • Support responding to requests from competent authorities, registries, and notified body.
    • Work closely with Product Quality Managers, Medical Safety, Quality Analytics and Customer Relations Staff to develop, review, edit and facilitate timely completion of PMS reports and other outputs of Safety Management Team.
    • Collaborate with key contributors to collect the necessary information to fulfill the requirements of the post market surveillance review.
    • Responsible for the annual renewal of Safety Surveillance Plans.
    • Perform other related duties as assigned by management.
    • Key Relationships: 

    Internal customers/business partners:

    • Medical Affairs
    • Customer Service
    • Regulatory Affairs
    • Manufacturing Site Quality Assurance

     

    External customers/business partners:

    • Company’s affiliates/Distributors(if required)
    • Audit/Inspection Organizations (NCAs, Notified Bodies, International Regulatory Agencies)

    Qualifications

    • 4 years Bachelor's level degree in engineering
    • Minimum of 1-3 years of experience in the Post Market Surveillance within Medical Device Industry is required.
    • Demonstrate analytical capabilities with the ability to summarize data into graphs, charts and statistics using software (Minitab) is required. 
    • Experience executing data management tasks is preferred. Ability to use Excel, MS Access for data analysis, basic understanding of a statistical software language is preferred.
    • Experience with technical writing/ a document are required. Ability to write and communicate in a professional manner, including generating and presenting well-written reports and presentations is required.

    Be Aware of Recruiting Fraud

    Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

     

    To learn more please read Valeant’s Job Offer Fraud Statement.

     

     

    Valeant Pharmaceuticals International, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

     

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