Vigilance Reporting Specialist

Clinical Research, Other

South East (Excluding London)

£Competitive

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Reference: 177797

* This Vacancy Has Now Expired *

Vigilance Reporting Specialist - Berks/Bucks - Permanent Role



Reporting to the Associate Director Product Surveillance, the Vigilance Reporting Specialist will be responsible for:



  • Analysing and managing all requests related to complaints and adverse events from Competent Authorities, Notified Bodies and other external or internal requesters, collaborating with the Quality Engineering group.

  • Supporting the regional Product Surveillance team with its vigilance reporting activities as required and improving the vigilance reporting process across EAME.

  • Addressing general administrative tasks associated with the Quality System at Marlow site.



The employee must conduct their work activities in compliance with all relevant regulations as well as company policies, procedures, values and objectives. The employee is expected to be fully capable of performing all of the tasks encompassed within this role and may be given other activities, projects and assignments as required.


Education and Experience:



  • Science or related degree level qualification preferred or experience in a similar environment

  • Experience in the healthcare, medical device or pharmaceutical industry is required

  • Experience in Adverse Event handling and vigilance reporting in accordance with applicable MEDDEV guidance and European/Emerging Market regulatory requirements for post market activities is required

  • Experience in direct interactions with Competent Authorities and other regulators is highly desirable



Knowledge:



  • Expert knowledge of vigilance reporting within EEA and EAME region. Includes Council Directive 93/42/EEC (Medical Device Directive)

  • Good understanding of all other applicable regulatory requirements would be an advantage:

    • FDA's 21 CFR Part 820 (Quality System Regulation), 21 CFR Part 803 (MDR Regulation) and 21 CFR Part 11 (Electronic Records; Electronic Signatures)

    • ISO 13485 and the Canadian Medical Device Regulations and the Australian Therapeutics Goods Administration regulations



  • Awareness of Good Documentation practices applicable to Medical Device regulatory requirements would be an advantage




Star is a full service resourcing and outsourcing company which resources at all levels for pharmaceutical, medical devices and technology, clinical research and healthcare communications companies in the UK and Ireland on a headcount and outsourced basis. If you haven't heard from us within 7 working days of submitting your application, please assume that you haven't been successful on this occasion. We wish you the best of luck with your job search.




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