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Pharmacovigilance (PV) Medical Writer

JOB DESCRIPTION

Principal Functions

The Pharmacovigilance (PV) Medical Writer is responsible for:

  • Medical writing including:
    • Scheduling of PSURs
    • PSURs
    • PADERs
    • ASRs
    • DSURs
    • RMPs
    • Clinical Study Reports
    • QC and review of all written output from the operations team as required
  • Signal Detection
    • Scheduling
    • Develop tracking log
    • Track HMA website for signals and MHRA drug safety update
    • Assessment and report writing – harmonise with PSUR section
    • Investigation
    • Review of Eudravigilance for product specific signals
    • Escalation of suspected signals through appropriate channels
    • Representation at safety committee level
  • Monthly Reports
    • Client / QPPV reports
      • Signal detection
      • Enhanced surveillance terms
      • Emerging safety concerns
      • PSUR schedule
      • Audits responses as appropriate
      • Safety committee meetings / action plans
      • Other
    • Participate in meetings to discuss monthly reports

Resources required:

  • Access to reports from ARISg such as E2C Line Listings and Summary Tabulations
  • MA tables
  • Communication channels with operations team in Zagreb and Krakow

Line Management:

  • The PV Medical Writer will report to the PV Manager
  • Mentoring/Line Management of PV Associates in PSUR writing.

Skills

  • Interpersonal, written and verbal communication skills.
  • Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
  • Good IT skills.
  • Willingness to work in a matrix environment and to value the importance of teamwork.

Education

  • The PV Medical Writer should ideally be a Life Science graduate, or have equivalent nursing or medical qualifications.

Language Skills

  • Good English

Minimum Work Experience

3 years pharmacovigilance including 2 years PSUR writing.

Travel

Some

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To apply, please send us a letter of introduction and your CV in English through the email application below.
Only short-listed candidates will be contacted.

For more information and to submit application, please contact careers@primevigilance.com.

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