Valeant Pharmaceuticals

  • Specialist EU MDR, Global Device Complaints Management

    Job Location US-NJ-Bridgewater
    Job ID
    10505
    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 activities for all company medical products as assigned.

     

    The position will include interaction and communication with internal business stakeholders.

    Responsibilities

    • Assist in the management of information regarding Post Market Surveillance activities as directed. Initial assignment will be the EU-MDR implementation project, including assessment for pre and post-marketing medical device complaint management activities including:
      • Receives, documents and evaluates information
      • Evaluates and engages appropriate management for critical and/or unusual events.
      • Liaises with internal functions (Quality, Regulatory, Medical Affairs, Customer Service, Manufacturing and R&D) to gather critical input data into medical device event PMS reports and/or Standard Operating Procedures.
      • Compiles process metrics and reports
    • Assists local affiliates with the preparation and submission of PMS Reports or data when required. 
    • Coordinates and prepares responses to competent authority inquiry’s associated with medical device report submission (Serious Injury and/or Device Malfunction).
    • Participate in preparation for Notified Body audits and or Competent Authority Inspections.
    • When required, support root cause investigations and participates in CAPA (Corrective and Preventive Action) activities.
    • Supports complaint handling trending activities.
    • Supports complaint handling trending activities.
    • Generates complaint data reports for other departments, when requested.
    • As required, supports department projects and/or participates in cross functional projects.
    • Generates periodic reports as requested per government agencies and/or Notified Bodies.
    • Performs all other duties as assigned.
    • Key Relationships: 

    Internal customers/business partners:

    • Medical Affairs
    • Customer Service
    • Regulatory Affairs
    • Research and Development
    • Design Quality Assurance
    • External Manufacturing Quality Assurance
    • Manufacturing Site Quality Assurance

     

    External customers/business partners:

    • Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)

    Qualifications

    • Bachelor‘s degree in scientific or business related discipline required (Biomedical Engineering, Pharmacy, Science, etc.).
    • Position requires strong written, oral and listening communication skills in order to interact with customer and other professionals.
    • Must be able to generate and organize clear, concise responses when communicating with various levels of management.
    • Superior organizational skills to be able to manage challenging deadlines.
    • Adjusts to change with minimum or no interruption.
    • Recognizes problems and suggests applicable solutions.
    • Able to perform job function with minor supervision and make independent decisions, where appropriate.
    • Proficient in the use of personal computers, including database management, trending and word processing.
    • Minimum of 2-3 years related work experience 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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