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Contractor - Manager, Pharmacovigilance LATAM

Ultragenyx · São Paulo

New
Contrato 🇬🇧 English
Pharmacovigilance

Job description

About the role

Ultragenyx is seeking a Contractor – Manager, Pharmacovigilance for the LATAM region. The role sits within the Global Drug Safety and Pharmacovigilance department and supports the Head of Pharmacovigilance LATAM in building and maintaining a compliant PV system for a growing portfolio of rare‑disease medicines.

Key responsibilities

  • Develop and maintain relationships with vendors, license partners and other internal and external stakeholders.
  • Support the establishment, maintenance and continuous improvement of the LATAM pharmacovigilance system to meet local regulatory and GVP requirements.
  • Maintain detailed knowledge of Ultragenyx products marketed in LATAM, including safety profiles and emerging safety concerns.
  • Contribute to timely submission of PV deliverables such as individual case safety reports (ICSRs), aggregate safety reports and safety queries to regulatory authorities.
  • Perform quality review of ICSR follow‑up activities across LATAM and ensure audit‑readiness.
  • Reconcile local submission compliance with PV service providers.

Required profile

  • Strong understanding of pharmacovigilance regulations and Good Pharmacovigilance Practices (GVP) in LATAM.
  • Experience managing PV activities for multiple products in a biotech or pharmaceutical environment.
  • Ability to work collaboratively with global DSPV teams and local stakeholders.
  • Fluency in English; proficiency in Spanish or Portuguese is advantageous.

Required skills

  • Pharmacovigilance
  • GVP compliance
  • ICSR management

Questions fréquentes

Le salaire n'est pas communiqué publiquement par le recruteur. Vous pouvez postuler et négocier directement avec Ultragenyx.
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Le contrat proposé est un Contrato basé à São Paulo.

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Published 7 hours ago

Expires 1 month from now

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Ultragenyx

São Paulo