Senior Vigilance Specialist - Chester, United Kingdom - Sinclair Pharma

Sinclair Pharma
Sinclair Pharma
Verified Company
Chester, United Kingdom

2 weeks ago

Tom O´Connor

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Tom O´Connor

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Description
Sinclair are currently recruiting for Senior Vigilance Specialist at their Chester office. The Senior Vigilance Specialist will be a member of the Vigilance Team and will report to the Vigilance Manager.

This position assures regulatory compliance and transparency of post-market surveillance, complaints and adverse events within the organisation, in line with global policies, procedures, and applicable regulations.


The Senior Vigilance Specialist will work closely with the Legal Manufacturers to manage the completeness and closure of complaints, adverse events and Field Safety Corrective Actions.

This position is responsible for the triage, communications and reporting to the EU Member State National Competent Authorities and other global regulators.


Hours of work: 37 hours (Monday to Friday)

Location:
Chester Business Park, Chester, CH4 9QT

About Sinclair


Our people embody being the best, mirroring our product and industry values to be the very best versions of themselves.

We essentially have our own language for people power. Self-owned and driven by our incredible world of passionate people.

Sinclair exists to create confidence Confidence in our products, for our customers and of course, for our people.

Our business is on a journey to become the dominant player in strategic global locations, rivalling our competition with diverse product development, by 2026.

Founded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range.

With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.


This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.


The Role

  • 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
  • Assist and support of any Field Safety Notices or Corrective Actions generated by the Company or a 3rd party manufacturer.
  • 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 Management System 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 management with claim and litigation cases
  • Support internal and external audits, change controls, artwork review, liaison with Compliance, Sales and Marketing departments.
  • Deputise for Vigilance Manager as required.

Your Skills & Experience - Do You Have What it Takes?

Essential:

  • Minimum 3 years' experience in Quality Assurance (Medical Device Vigilance) within a Medical Device or Aesthetics organisation
  • Working knowledge of the Medical Device Regulation and Medical Device Directive
  • Knowledge of other vigilance legislation and guidelines, e.g., US, Canadian regulations
  • Direct interaction with EU Member State National Competent Authorities and other global regulators
  • Excellent attention to detail when reviewing and preparing documentation
  • Organised, targetorientated, flexible, good time management skills
  • Strong written and oral communication skills
  • Excellent attention to detail when reviewing and preparing documentation
  • Fluency in written and spoken English

Desirable:

  • University Degree in a scientific field
  • Experience working across export markets and interacting with international distributors
  • Specific knowledge in dermatology/aesthetics
  • Experience working with drug/device combination products
  • Experience of relating clinical information to device function and cause assessment.
  • Experience of root cause analysis, including use of common tools

A bit about you - do you fit this description?

Role competencies:


  • Personal responsibility
  • Communication, impact and influence
  • Analytical and critical thinking capacity
  • Time manag
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