Head Medical and QPPV

1 semana atrás

Lisboa, Lisboa, Portugal Michael Page Tempo inteiro

O nosso cliente pretende reforçar a sua equipa Médica com um Head Medical and QPPV.

Sobre o nosso cliente

Multinacional da Indústria Farmacêutica.

Principais responsabilidades

  • Garantir o funcionamento e conformidade do Sistema de Farmacovigilância de acordo com a legislação europeia e as Good Pharmacovigilance Practices;
  • Organizar e gerir todas as actividades do sistema local de farmacovigilância;
  • Coordenar orçamentos e a subcontratação de serviços de farmacovigilância;
  • Assegurar a gestão e manutenção de acordos de farmacovigilância com parceiros externos;
  • Promover formação interna em farmacovigilância para todo o pessoal relevante;
  • Monitorizar continuamente o balanço benefício-risco dos produtos e assegurar a actualização da documentação de segurança;
  • Actuar como ponto de contacto 24h para autoridades de saúde e garantir comunicação eficaz em situações de segurança e crises;
  • Supervisionar a implementação de medidas correctivas e de melhoria do sistema, garantindo o cumprimento de procedimentos e da legislação aplicável;
  • Apoiar tecnicamente a gestão de casos de reacções adversas e a monitorização de sinais, incluindo avaliações de benefício-risco e documentos agregados de segurança;
  • Participar e preparar a organização para auditorias e inspeções de farmacovigilância.

Perfil desejado

  • Mestrado Integrado em Medicina;
  • Experiência em função semelhante de, pelo menos, 3 anos, ou experiência em farmacovigilância de, pelo menos, 5 anos;
  • Conhecimento da legislação e das orientações de farmacovigilância na UE;
  • Conhecimento de codificação de reacções adversas (MedDRA);
  • Formação em Eudravigilance;
  • Experiência na utilização de bases de dados de segurança;
  • Conhecimento de inglês, nível intermédio-alto ou avançado.

Benefícios adicionais

Integrar uma equipa apaixonada, colaborativa e com mentalidade de crescimento.

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