Contractor - Manager, Pharmacovigilance LATAM
Ultragenyx · São Paulo
Descrição do cargo
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
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Publicado há 6 horas
Expira em 1 mês
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Ultragenyx
São Paulo
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