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Pharmacovigilance / Drug Safety

Pharmacovigilance Manager

Details

  • Full-time permanent position
  • Office based in South-West England
  • Competitive package
  • Global pharma company

The Role

  • NO direct reports /line management
  • The role will involve, and will therefore require, previous relevant experience of the following: Pharmacovigilance System Master File (PSMF): Maintenance of the Pharmacovigilance System and PSMF
  • 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 sources including spontaneous reports, literature sources, National Regulatory Authorities and the EMA
  • Signal Management: Signal management from signal detection through to assessment and recommendation for action
  • Risk Management and Minimisation: Production, review and maintenance of Risk Management Plans and implementation of risk minimisation activities including effective use of product labelling
    and (when required) additional materials.
  • EudraVigilance: Management of case data, signal detection activities on the EudraVigilance dataset, maintenance of product information
  • Pharmacovigilance Agreements: Production, review and maintenance of effective Safety Data Exchange Agreements between the company and its business partners.
  • Literature review: Review of safety information published in the scientific literature.
  • 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.
  • Product Maintenance & Development: Authoring of safety-related information including updates to product labelling (SmPC, PIL, packaging) and coordination of associated regulatory activities. Supporting new MA applications, lifecycle maintenance and renewal activities.
  • Medicines Information: Provision of a Medicines Information service – managing resources to deal with medical, pharmaceutical and technical enquiries

Full job description available on application

 

The Candidate

  • Candidates should have a life science degree in Pharmacy or an additional postgraduate degree would be an advantage
  • A minimum of 8 to 10 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 – the ability to effectively communicate information, verbally and in writing, at levels appropriate to the needs of different internal and external customers including business partners and healthcare professionals.
  • Only candidates with existing right to work in the UK/EU will be considered

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