LIBBS FARMACÊUTICA LTDA logo
LIBBS FARMACÊUTICA LTDA

Porque se trata da vida

Analista de Farmacovigilância Sênior – Pesquisa Clínica

Clinical ResearchClinical ResearchFull TimeRemoteSeniorTeam 1,001-5,000Since 1958H1B No SponsorCompany SiteLinkedIn

Location

Brazil

Posted

8 days ago

Salary

0

Seniority

Senior

Bachelor DegreePortugueseEnglish

Job Description

Analista de Farmacovigilância Sênior – Pesquisa Clínica

LIBBS FARMACÊUTICA LTDA

• Atuar na avaliação e monitoramento de dados de segurança de medicamentos comercializados e em desenvolvimento, garantindo conformidade com as regulamentações nacionais e internacionais de farmacovigilância. • Conduzir atividades relacionadas à farmacovigilância em estudos clínicos, assegurando o adequado gerenciamento de eventos adversos e o cumprimento dos requisitos regulatórios aplicáveis. • Apoiar a elaboração, revisão e implementação de procedimentos, acordos e fluxos relacionados à farmacovigilância em pesquisa clínica. • Realizar interface contínua com áreas internas como Pesquisa Clínica, Assuntos Regulatórios, SAC, Evidências Médico-Científicas, Marketing e demais áreas de negócios. • Participar de projetos estratégicos relacionados ao desenvolvimento de novos produtos, contribuindo com avaliações de segurança e definições de processos de farmacovigilância. • Atuar junto a parceiros externos, CROs, investigadores e empresas parceiras, garantindo alinhamento técnico, troca de informações e cumprimento dos acordos de farmacovigilância. • Contribuir para a elaboração de avaliações benefício-risco, análises de segurança e atividades de detecção de sinais. • Apoiar auditorias, inspeções regulatórias e processos de due diligence relacionados à área. • Participar da estruturação e melhoria contínua dos processos de farmacovigilância, promovendo qualidade, rastreabilidade e confiabilidade dos dados. • Acompanhar cronogramas, entregas e demandas relacionadas aos projetos sob sua responsabilidade.

Job Requirements

  • Ensino superior completo em Farmácia ou áreas correlatas da Saúde.
  • Experiência sólida em Farmacovigilância.
  • Vivência com atividades de farmacovigilância relacionadas à Pesquisa Clínica.
  • Conhecimento das regulamentações nacionais e internacionais aplicáveis às Boas Práticas de Farmacovigilância e Boas Práticas Clínicas.
  • Experiência na gestão e avaliação de eventos adversos provenientes de estudos clínicos.
  • Vivência na elaboração e/ou gestão de acordos de farmacovigilância e processos relacionados.
  • Experiência em interação com áreas multidisciplinares e parceiros externos.
  • Inglês avançado para participação em reuniões, alinhamentos e interações com parceiros internacionais.
  • Conhecimento em Boas Práticas de Farmacovigilância (GVP) e requisitos regulatórios aplicáveis.

Benefits

  • Vale Refeição;
  • Vale Alimentação;
  • Medicamentos Libbs - 100%;
  • Convênio Farmácia – Vidalink;
  • PPR - Programa de Participação dos Lucros e Resultados da companhia;
  • Estacionamento, vale-transporte ou fretado (aplicável para atuação em turnos e condicionado à disponibilidade de linhas, que atendem regiões localizadas em um raio reto de até 40 km da unidade);
  • Programa USE: subsídio para compra do equipamento que será utilizado para o trabalho, podendo utilizá-lo para fins pessoais;
  • Benefícios flexíveis (TotalPass, seguro de vida, previdência privada, assistência médica, odontológica e auxílio alimentação).

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