Posted on Oct 12th 2019

PMS Specialist

中国,上海,上海

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,上海,上海

Full time

431917

保存职位

Job Title

PMS Specialist

Job Description

Job Description

In this role, you have the opportunity to
 

  • Deploy and maintain quality management system for S&SD professional service delivery, ensure the PSD team’s daily operation process to comply with quality management system, external quality standards and related regulations requirements.
     

You are responsible for

Feedback Handling Management in G. China

  • Manages & monitors the Philips customer feedback system including the receipt and subsequent closure of field related issue (per regulatory agency requirements when required). Provide the analysis report accordingly.
  • Executes feedback review
  • Screening for data consistency and quality check
  • Ensure customer acknowledgement when necessary
  • Assign local feedback owner according local rules
  • Submit the feedback to the local feedback owner and the BU
  • Ensures communication with BU’s with regard to adverse events reporting.
  • Monitor feedback owners for tracking feedbacks from initiation to resolution in his/her assigned area
  • Participates/supports feedback owner in designing customer communication

Adverse Event (AE) Handling

  • Identify the reportable AE.
  • Lead the cross-functional teams to work out proper report.
  • Ensure all adverse events, which include local and oversea AE reporting are handled in timely manner and comply with regulation and Philips requirements.
  • Perform Customer/Competent Authority communication.

Recall & Correction Management timely

  • Lead the cross-functional team to handle all the recalls in timely manner
  • Receives the BU Q&R communication and analyze it with the relevant people
  • Tracks product recalls for Mandatory field change orders (FCOs) to closure.
  • Ensure communication package localization
  • Perform Customer/Competent Authority communication.
  • Informs KM Post-Market Surveillance Officer on MA FCO completion and Competent Authority of his/her assigned countries.
  • Ensure Philips Healthcare China to comply with all regulations requirements.

Post-Market Surveillance monitoring

  • Ensures traceability and recording of all compulsory related data.

You are a part of

  • Greater China Market quality team with international exposure.

To succeed in this role, you should have the following skills and experience

  • Bachelor degree or above, BS in Science or equivalent.
  • Quality background is essential.
  • Minimum of 5 years’ experience working in disciplined regulated industry.
  • Experience with working with CFDA, Shanghai FDA is preferred.
  • Rich experience in PMS affairs handling.
  • Well understanding with ISO9001 and ISO13485 standards, knowledge of EU MDD and FDA QSR is an advantage.
  • Family with China CFDA, CIQ, consuming products related regulations.
  • Excellent communication and interpersonal skills.
  • Positive attitude, will to take the lead for the responsible projects.
  • Computer skills including database management, word processing and spreadsheets are also necessary.
  • Good in written and spoken  English and Mandarin

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.

  • A professional but fun workplace, A healthy work-life balance environment;
  • An energetic, genuine, inventive, supportive and dynamic team atmosphere.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 2.5 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there,you can also learn about our recruitment process, or find answers to some of the frequently asked questions.

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Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did. Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team. We have over 80,000+ brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while tranforming themselves personally and professionally. Working at Philips is more than a job. It's an experience filled with unexcepted moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you.

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