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Local Safety Officer

Local Safety Officer

  • Location

    Berkshire, England

  • Sector:

    Pharmacovigilance

  • Job type:

    Permanent

  • Salary:

    Negotiable

  • Contact:

    Matt Thomas

  • Contact email:

    matt.thomas@pharma-partners.co.uk

  • Job ref:

    24568_1626857963

  • Published:

    3 months ago

  • Expiry date:

    2021-08-20

  • Consultant:

    #

Job title: Local Safety Officer

A small pharmaceutical business in Berkshire with upcoming product launches are seeking a Local Safety Officer. This role will sit in a cross-functional team, standing in for the functional head when required. Candidates must have extensive UK/IE pharmacovigilance experience in addition to prior line management/mentoring experience. This is a flexible opportunity with 2 days per week required in the office.

Responsibilities:

  • Local processing of spontaneous reports received from health care professionals, non-healthcare professionals, authorities, literature and conference presentations
  • Performs data entry into Global Intake Tool/ Argus/ or its equivalent for processing safety reports
  • Manages product quality complaints in collaboration with the regional Quality team
  • Notifies safety signals including Emerging Safety Issues to the UK Medicines and Healthcare products Regulatory Agency (MHRA) within the specified timelines, upon receipt from the GPV Signal Management Team
  • Reporting to the QRVI manager will support the QRVI manager as their deputy to provide operational management and leadership in all aspects to the QRVI team and ensure that team activities meet the objectives of both internal and external stakeholders
  • Is the Risk Management Plan (RMP) Lead and liaises with the appropriate functions to obtain approval of the associated additional Risk Minimisation Measures (aRMMs) from Health Authorities and in accordance with our standard operating procedures (SOPS)

Requirements:

  • Minimum of 4 years PV experience, ideally with previous experience of involvement in MHRA inspections
  • Previous management/mentoring experience is essential
  • Graduate science degree in health/life sciences
  • Flexible approach, readily adapting to changing circumstances and new opportunities; encourages, leads, facilitates and drives change where appropriate

Salary and benefits:

A competitive salary, annual bonus, health & dental care and further benefits are on offer

To apply for this position or hear further details then please contact Matt Thomas via matt.thomas@pharma-partners.co.uk