Pharmacovigilance Co-ordinator

2 weeks ago

London, United Kingdom Qube Recruitment Full time

Our client, based in Dartford, were established in 2011. UK owned they are now expanding and are looking to recruit a Pharmacovigilance Co-ordinator.

Job Description:

  • Develop and approve artwork components and patient information (SPC, PIL, cartons and labelling) and associated mock-ups.
  • Liaise with project managers for implementation of updated product information.
  • Co-ordinate with external pharmacovigilance contractors for submission of safety variations and PSUSA variations
  • Co-ordinate with pharmacovigilance contractors for updating and approval of risk minimisation material.
  • Responsible for maintaining and distribution of Risk minimisation material through external contractors.
  • Experience in uploading the product information to databases like EMC.
  • Review and provide sales data for PSUR reporting.
  • Conduct regular meetings with external pharmacovigilance contactors for the ongoing pharmacovigilance activities.
  • Responsible for ensuring all the relevant contracts are in place for pharmacovigilance activities carried out via external parties in UK & EU.
  • Responsible for completing detailed monthly PV Summaries.

Qualifications and Experience:

  • Educated to degree level in science or equivalent experience.
  • Minimum 3 years of experience in the Regulatory Affairs & Pharmacovigilance
  • Proficiency in the use of MS Office suite (Excel, PowerPoint)
  • Ability to take initiative and work with different departments as a team player within the organisation.

Monday to Friday: Full Time

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