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Senior Pharmacovigilance Officer – Team Lead / Case Processing Manager

PrimeVigilance · Belgrade

Senior 🇬🇧 English
ICSR management

Description du poste

About the role

PrimeVigilance is seeking a Senior Pharmacovigilance Officer to lead a team responsible for Individual Case Safety Report (ICSR) management on medical‑device projects. You will act as the primary point of contact for clients, ensure high‑quality case processing, and drive continuous improvement across the portfolio.

Key responsibilities

  • Lead and line‑manage the ICSR team for assigned projects, distributing tasks and overseeing workflow.
  • Maintain effective cooperation with clients on all ICSR‑related matters.
  • Create and monitor project‑specific KPIs, optimise procedures and training to increase team efficiency.
  • Propose and implement process changes in collaboration with the ICSR Operational Lead.
  • Manage ICSR deviations, review trackers and timesheets for accuracy.
  • Perform ICSR processing and second‑level quality checks.
  • Support other departments as directed and act as the subject‑matter expert for the team.
  • Serve as Local Contact Person for Pharmacovigilance (LCPPV) and Person Responsible for Local Screening (PRLS) for designated languages/countries.

Required profile

  • Life‑science degree (pharmacy, nursing or related) or equivalent pharmacovigilance experience.
  • Minimum 1 year of line‑manager experience within pharmacovigilance.
  • Specific experience with medical‑device safety reporting.
  • Fluent English (spoken and written) with excellent communication skills.
  • Strong organisational, delegation and planning abilities.

Required skills

  • ICSR management
  • Pharmacovigilance processes
  • Medical‑device regulatory compliance

What we offer

  • Opportunity to work in a global, purpose‑driven organization.
  • Collaborative culture built on kindness, flexibility and growth.

Questions fréquentes

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PrimeVigilance

Belgrade