Senior Regulatory Affairs

3 semanas atrás

Lisboa, Portugal Grabjobs Portugal Tempo inteiro

A bene farmacêutica, é uma sucursal portuguesa da empresa alemã bene-Arzneimittel GmbH, que distribui os seus produtos em Portugal há mais de 60 anos, com uma dinâmica cada vez mais crescente tanto no mercado farmacêutico português como de exportação. Procura integrar na sua equipa um Senior Regulatory Affairs & Local Safety Officer. Sobre a função: Efetuar todas as atividades relacionadas com a gestão do ciclo de vida dos medicamentos, nomeadamente através da gestão de processos regulamentares, na garantia de conformidade regulamentar dos processos e compliance com a legislação europeia e nacional e guidelines aplicáveis.
Gestão, aprovação e arquivo de materiais de embalagens, material promocional e eventos promocionais e educacionais.
Efetuar todas as atividades relacionadas o sistema de Farmacovigilância da bene farmacêutica, em especial gestão de casos e pesquisa bibliográfica local.
Principais responsabilidades - Submissão e manutenção de AIMs;
- Submissão e manutenção registos de dispositivos médicos; produtos de saúde e cosméticos;
- Revisão e aprovação de materiais promocionais e de materiais de embalagem;
- Revisão da Compliance regulamentar nos eventos educacionais e promocionais;
- Assegurar Compliance dos produtos com a legislação europeia e nacional;
- Participação nos processos de revisão de preços;
- Atualização de bases de dados internas e externas.
- Deteção, processamento, follow-up e transmissão eletrónica de reações adversas;
- Pesquisa bibliográfica nacional e pesquisa bibliográfica internacional;
- Apoio na elaboração de Relatórios Periódicos de Segurança (RPS), Planos de Gestão de Risco (PGR) ou outras medidas urgentes de segurança.
Competências - Licenciatura em Ciências Farmacêuticas;
- Experiência profissional na área em funções similares a mais de 7 anos;
- Conhecimentos sobre Legislação Farmacêutica nomeadamente, regulação nacional e europeia sobre os medicamentos;
- Conhecimentos da legislação em Farmacovigilância;
- Compreensão das atividades regulamentares e do seu impacto noutras áreas funcionais ou processos da empresa;
- Conhecimento do mercado farmacêutico;
- Inglês falado e escrito;
- Certificado de Competências Profissionais (CCP) – preferencial;
- Bons conhecimentos de informática na ótica do utilizador, nomeadamente em Office ;
- Boa capacidade de observação, comunicação e relacionamento interpessoal;
- Capacidade de iniciativa, organização e espírito critico;
- Trabalho em equipa;
- Orientação para resultados.
Se considera que possui o perfil descrito e gostaria de integrar uma empresa sólida, com um forte branding e notoriedade no mercado, que proporciona uma política de remuneração e benefícios atrativa e formação contínua, envie a sua candidatura e "Curriculum Vitae" para:

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