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Analista de farmacovigilancia – Latin America

Galderma · District fédéral

🇪🇸 Español
Quality management

Job description

About the role

Galderma is seeking a Pharmacovigilance Analyst to support its Latin America post‑marketing surveillance activities. The role ensures safety data are collected, evaluated and reported in compliance with local, regional and global regulations, contributing to the safe use of Galderma’s dermatology products.

Key responsibilities

  • Manage quality of pharmacovigilance procedures, implement audit findings and drive improvement projects across Latin America.
  • Maintain continuous communication with the EU‑QPPV to ensure compliance with European and Latin American regulations.
  • Respond to Health Authority safety information requests 24/7, meeting regulatory deadlines.
  • Review, submit and archive adverse event reports to Global Pharmacovigilance, ensuring adherence to legal and contractual obligations.
  • Develop, update and approve Latin America‑specific pharmacovigilance procedures based on regulatory changes.
  • Coordinate and deliver pharmacovigilance training for all Galderma employees involved in post‑marketing surveillance.

Required profile

  • Experience in pharmacovigilance and post‑marketing surveillance within the pharmaceutical or biotech sector.
  • Strong knowledge of Latin American pharmacovigilance regulations and global safety guidelines.
  • Ability to work on a 24/7 on‑call basis for safety queries.
  • Excellent communication skills for interaction with global safety teams and health authorities.

Required skills

  • Pharmacovigilance processes and adverse event reporting.
  • Regulatory compliance and quality management.

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Published 3 months ago

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Galderma

District fédéral