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Senior Pharmacovigilance Specialist

Viatris · Riyadh Region

Senior 🇬🇧 English

Job description

About the role

Viatris Arabia is seeking a Senior Pharmacovigilance Specialist to act as the local Qualified Person for Pharmacovigilance (QPPV) and Affiliate Safety Representative (ASR) for Saudi Arabia. The role ensures the PV system complies with both Viatris global standards and Saudi regulations, supporting the safety of medicines across the market.

Key responsibilities

  • Organise, implement and continuously improve the Affiliate PV system for all Viatris entities in KSA.
  • Provide after‑hours availability in line with local regulatory requirements.
  • Manage Individual Case Safety Reports (ICSRs) – receipt, documentation, forwarding, tracking and follow‑up.
  • Collect safety data for interventional clinical trials and company‑initiated epidemiological programs (PSPs, MRPs, registries, non‑interventional studies).
  • Screen Viatris‑sponsored social media and local medical/scientific literature for safety information, ensuring proper translation and reconciliation.
  • Maintain patient confidentiality and privacy according to local laws.
  • Handle adverse event reports, product quality complaints and safety communications from internal teams, healthcare professionals and regulatory authorities.
  • Provide periodic safety reporting and communicate any regulatory changes to the global safety team.

Required profile

  • Extensive experience in pharmacovigilance, preferably in a QPPV or safety representative capacity.
  • In‑depth knowledge of Saudi Arabian pharmacovigilance regulations and international guidelines.
  • Proven ability to lead training programs and follow‑up activities with distributors.
  • Strong organizational skills and ability to work autonomously after hours.

Required skills

    What we offer

    • Opportunity to lead pharmacovigilance activities for a global healthcare company.
    • Exposure to a wide range of safety data sources, including clinical trials, real‑world evidence and social media.
    • Professional development within a multinational environment.

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    Published 3 months ago

    25 views · 0 interested

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    Viatris

    Riyadh Region