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Senior Vigilance Specialist

Consult
Job LocationLondon
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

Working for a global aesthetics company, this position will report into the Vigilance Manager and oversee the vigilance on a global scale across a broad portfolio of complementary products; including medical devices and cosmetics. This person will ideallybe based in England as travel to the office will be required on a monthly basis. Periodic international travel to both manufacturing sites and Sinclair-owned subsidiaries may also be required.Responsibilities:

  • To manage Customer Complaints, Post Market Surveillance and Periodic Safety Update Report activities.
  • Preparation, review, and submission of Post Market Surveillance Data, including PMS Tracking, leading PMS Board Meetings, producing PMS/ PSUR Reports, PMCF Plans and PMCF Evaluation Reports, and complaint trending.
  • Ensuring Vigilance and Post Market Surveillance data is administered in a timely manner in EUDAMED
  • To support responses to the National Competent Authorities and Regulatory Agencies in relation to Adverse Events and Field Safety Corrective Actions
  • Working with Manufacturing and Research and Development departments across all the Manufacturing entities to ensure problems are effectively resolved and investigations are fully documented. Instigate and implement effective corrective and preventive actions.
  • Reporting to Vigilance Manager on the effectiveness of the vigilance processes within the Quality Management System and any needs for improvement
  • To ensure compliance to all applicable quality standards, regulations and internal procedures by proactively interpreting Vigilance requirements, and devising and implementing solutions to support the maintenance and enhancement of the Quality ManagementSystem and quality documentation throughout the business
  • Travel to Manufacturing sites, training workshops and other company events may be required to support the Vigilance processes
  • Support internal and external audits, change controls, artwork review, liaison with Compliance, Sales and Marketing departments.
About You:
  • Educated to University degree or equivalent preferably
  • Excellent attention to detail when reviewing and preparing documentation
  • Computer skills (including but not limited to Windows and MS Office).
  • Orientation towards achievement and ability to learn
  • Travel to the office required on a montly basis
If youre interested in the above role then please click apply or get in touch to discuss further.Consult will endeavour to contact candidates within 14 days of application. However, if you do not hear back after 2 weeks then please assume on this occasion, unfortunately, you have not been successful.

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