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PV Officer Grade II

DG Partnership Ltd
Job LocationHarlow
EducationNot Mentioned
Salary£22,000 - £25,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

PV Officer Grade II – £22,000 to £25,000 – Harlow, EssexThe RoleWe are looking for a competent and capable PV Officer Grade II with at least two years’ experience in processing ICSRs and completing QC on ISCRs. Reporting to the Operational Group Lead, you will be responsible for completing day to day pharmacovigilance activities. This is an exciting opportunity to take on a fresh challenge and develop your career with a dynamic and growing company.The key responsibilities of a PV Officer Grade II include, but are not limited to:

  • Using and maintaining knowledge of the company safety database (training will be provided)
  • Performing triage (assessment) of ICSRs
  • Logging and entering cases accurately into the safety database
  • Ensuring ICSR documentation is correctly stored within the company documentation system
  • Performing accurate and timely quality control of ICSRs
  • Highlighting areas of concern and/or discrepancies to the Operational Group Lead when related to ICSRs
  • Performing literature searches and review for AEs
  • Performing Eudravigilance and XEVMPD/SPOR company and user updates and registration
  • Acquiring and maintaining up to date knowledge of global safety regulations for medicines
  • Managing and keeping up to date a personal training record
  • Performing new tasks as necessary to support the Department
    • The CompanyDiamond Pharma Services is a leading technical and scientific consulting group serving the biotechnology and pharmaceutical industry with a Global HQ in the UK and EU HQ in Ireland. Our emphasis is on regulatory affairs, product development, pharmacovigilance, compliance and patient information leaflet testing.Our clients range from virtual start-up companies to the largest multi-national corporations. Our expertise includes products of recombinant DNA and hybridoma technology, nucleotide based products (RNA and DNA), synthetic peptides, chemical entities (innovative and generic), vaccines (therapeutic and prophylactic), blood products and advanced therapy medicinal products (gene therapy products).The PersonThe key skills and qualities of a PV Officer Grade II:
  • Has science degree; with at least 2 years’ experience in processing ICSRs and completing QC on ICSRs;
  • Ability to perform and review literature searches; ability to identify and author CAPA; and have a good understanding of Pharmacovigilance
  • Able to process and QC ICSRs
  • Good understanding of Pharmacovigilance
  • Ability to report ICSRs to Eudravigilance
  • Ability to register and modify users and company entities in XEVMPD
  • An understanding of aggregate reporting and signal detection
    • If you are keen on joining this exciting, forward thinking company and taking the next step in your career, then please click the apply now button to find out more.

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