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Vacancy summary

Reference: 07341

Job Type: Permanent

Date Posted: 15 August 2018

  • Join a global clinical research organisation
  • Use your PV / drug safety quality skills to contribute to the strong industry reputation of a niche CRO
  • Fantastic step up in your PV Quality career
  • Be part of an expanding Pharmacovigilance Quality team (multicultural / multinational)

Pharmacovigilance Quality Specialist

As the PV Quality Specialist within this forward-thinking organisation based in the Surrey, you will be working on clinical trials and ensuring regulatory reporting compliance.

To be successful in this role, you will need to have prior experience in ICSR case file quality assessments and archiving procedures, audits & investigations, periodic review of all training records for the company new starters and existing staff.

KEY RESPONSIBILITIES:

  • Quality assessment of ICSR case file and safety reports
  • Reviewing, tracking and submission of PSURs and other periodic reports
  • Quality checks of all company processes (training, database validation, PSURs, ICSRs, Safety Reviews)
  • Creating, reviewing, maintaining, training other staff and Quality assessment on SOP
  • Responsible for checking and setting up a new client
  • Reviewing training documents and schedules for new starters
  • Assessment of client and Regulatory Authority Audit report and CAPA overview
  • Attending meetings with clients and Audits and making sure the company is fully compliance

REQUIREMENTS:

  • Ideally degree educated (in a Scientific discipline) although all profiles with strong quality compliance management in the pharmaceutical industry, will be considered
  • You'll be a highly organised and efficient approach with a management style which promotes open communication and fosters teamwork across all stakeholders
  • Excellent attention to detail and ability to ensure documents are properly filed and stored
  • People management and training skills

Apply today for an informal conversation to discuss your career path and how our client could progress you forward in the direction you want to take!

Park Street People Ltd is an Equal Opportunities Employer. We do not discriminate on the grounds of age, race, gender, disability, creed or sexual orientation and comply with all relevant UK legislation. We are acting as an Employment Business in relation to this role.

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*Terms and conditions apply


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