CAREERS

Pharmacovigilance (PV) Medical Writer

Location: Zagreb, Croatia

We are looking for an experienced pharmacovigilance medical writer to join our team in Zagreb. The Pharmacovigilance (PV) Medical Writer will be 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.

  • Good English
  • 3 years pharmacovigilance including 2 years PSUR writing.
  • Ability to travel between international locations

To apply, please send us a letter of introduction and your CV in English through the email address below.

Only short-listed candidates will be contacted.

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