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Philips Vigilance Reporting Specialist in Pune, India

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In this role, you have the opportunity to

Work with a variety of diverse persons within the company such as Engineers, Scientists, Field Service & Application Engineers and Manufacturing personnel to facilitate reportable device events in accordance with written procedures and global reporting requirements.

You are responsible for

  • Works together with Complaint Investigators during initial check/ reportability determination.

  • Reviews complaints to ensure that all information needed for Reporting/MDRs is present; determines if further investigation is needed and tracks investigation to conclusion

  • Follows up reporting decisions together with complaint investigators till investigation is completed.

  • Writes MDRs/MIR reports ensuring that the information is accurate and complete as per applicable requirements.

  • Works together with Complaint Investigators to address Competent Authority inquiries and prepares the responses for such inquiries.

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

  • Bachelor’s degree.

  • Working knowledge of appropriate global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169.

  • Good Verbal and written communication skills.

  • Analytical skills and focus on detail.

  • Teamwork in and outside Q&R.

  • Fluent in English (verbal and written).

  • Product Knowledge is preferred.

  • Medical Device and or other regulated industry (e.g. Pharma, IVD) is preferred

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.

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 .

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