Posted on Oct 12th 2019

Sr. Vigilance Manager

中国,广东,深圳

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,广东,深圳

Full time

470205

保存职位

Job Title

Sr. Vigilance Manager

Job Description

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 80,000, wonderfully unique individuals, with two things in common. An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to

Help transform Post Market Surveillance (PMS), which will help improve the lives of millions of people while advancing Philips’s journey as a global leader in Health Technology.

You will use your vigilance reporting experience and expertise to lead a team of Vigilance Reporting Specialists and implement globally compliant and Philips standardized adverse event reporting policy and processes. 

You are responsible for

  • Enforcing standardized and simplified adverse event reporting processes
  • Providing leadership and subject matter expertise to a team of Vigilance Reporting Specialists who are responsible for world-wide adverse event reporting decision making and report submissions.
  • Introducing and implementing adverse event reporting processes and tools required to   ensure global regulatory compliance, quality, and patient safety.
  • Managing compliance to FDA regulations and other Regulatory Agencies.
  • Managing the oversight and review of adverse event reports globally
  • Actively participating in inspections and questions relating to the operation of complaint handling operations, processes and procedures in coordination with all other applicable company groups.
  • Establishes an effective Management Review process, including routine reporting.

You are a part of

As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interactions with Philips Business Group and the leadership. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being, and care for people around world.

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

  • Master’s or bachelor’s degree with > 5 years’ experience managing adverse event reporting activities with a preference towards bachelor’s degree or higher in biomedical engineering, science, healthcare, or medical profession.  
  • 5 years previous experience working as a biomedical engineer/risk manager OR in a licensed/certified capacity in a health care role such as an RN, NP, PA, MD, Respiratory Therapist, Radiation Technologist, Ultrasound Technologist, CT technologist, etc. OR previous experience with servicing or supporting Philips’s products in the field OR previous experience working as a Vigilance Reporting Specialist
  • 7-10 years’ experience Medical Device and or other regulated industry
  • Basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO1497, and ISO9001
  • Global post market surveillance regulation (21CFR, MDD93/42/EEC and other applicable global regulations), ISO14971 Risk Management.

How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.

Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.

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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

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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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