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Pharmacovigilance / Drug Safety

Senior Pharmacovigilance Officer

Details

  • Full-time permanent position
  • Part office based in Gloucestershire with some home working
  • Competitive package

The Role

  • Pharmacovigilance System Master File (PSMF): Maintenance of the Pharmacovigilance System and PSMF.
  • Quality Management Systems: Maintaining the PV Quality Management System and undertaking associated quality‐related activities including Audit, Compliance Monitoring and Quality Improvement. SOP authoring and management.
  • Post‐marketing safety data: Processing and reporting spontaneously received post‐marketing safety data including its receipt, tracking, coding, assessment and submission to regulatory authorities.
  • Safety Data Management: Maintenance of cumulative safety data received from all source including spontaneous reports, literature sources, National Regulatory Authorities and the EMA
  • Literature review: Review of safety information published in the scientific literature.
  • The role will also involve wider aspects of Medical Affairs, including Medicines Information, Pharmaceutical Regulatory Affairs and new product development.
  • Full job description available on application

The Candidate

  • A degree in the Life Sciences minimum. A degree in Pharmacy or an additional postgraduate degree would be an advantage.
  • A minimum of 3 to 5 years of relevant (post‐marketing) EU Pharmacovigilance experience.
  • A clear understanding of the current and developing legislation and the ability to apply this to the company Pharmacovigilance System and processes.
  • Outstanding communication and medical writing skills with exceptional attention to detail
  • Only candidates with existing right to work in the UK/EU will be considered

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