Philips Assistant Post Market Surveillance Mgr in Shanghai, China
Assistant Post Market Surveillance Manager
In this role, you have the opportunity to
• This position is intending to handle post-market surveillance activities including AE reporting, recall reporting and handling, customer feedback and maintaining the good working relationship with authorities in G. China.
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 Great china Q&R teamTo succeed in this role, you should have the following skills and experiencea) Education学历:
Bachelor degree or above, BS in Science or equivalent.
Technical background is essential.b) Experience工作经验:
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.c) Competency and Skills 能力和技能:
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 Mandarind) Travel Frequency出差频率:
V < 25% 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 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .