Pharmacovigilance regulatory reporting – home office

Responsabilidades

• Process safety data according to applicable regulations, guidelines, SOPs, and project requirements.
• Ensure compliance with quality, productivity, and delivery standards per project requirements.
• Track cases as applicable to the project plan.
• Identify and report quality problems to senior team members.
• Liaise with different functional team members and health care professionals to address project-related issues.
• Attend project team meetings and provide feedback to the operations manager on challenges, issues, or successes.

Requisitos

• Qualificações Mínimas
  • Bachelor’s degree in life sciences.
  • Advanced level of English, Spanish and Portuguese.
  • 1 year of experience in pharmacovigilance activities (mandatory).
  • Good knowledge of medical terminology and applicable safety databases.
  • Strong organizational skills, attention to detail, and ability to work independently and as part of a team.
• Qualificações Preferenciais
  • Experience specifically in regulatory reporting.
  • Previous experience working with Argus.

Marcado como: Análise de Dados, Assuntos Regulatórios, Compliance, Controle de Qualidade, Farmacêutico, Farmacologia, Relatórios