Pharmacovigilance Regulatory Reporting

IQVIA Argentina; São Paulo; Teletrabalho; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

Uma empresa de pesquisa clínica líder no setor procura um Especialista em Relatórios Regulatórios para trabalhar em 100% home office. O papel envolve processamento de dados de segurança, cumprimento de regulamentos de qualidade e colaboração com profissionais de saúde para garantir a conformidade regulatória. É necessário ter formação em ciências da vida e experiência em farmacovigilância.

Qualificações

• Nível avançado de inglês é obrigatório.
• Experiência de 2-3 anos em atividades de farmacovigilância com foco em relatórios regulatórios.
• Bom conhecimento de terminologia médica e bancos de dados de segurança.

Responsabilidades

• Processar dados de segurança conforme regulamentos e requisitos de projeto.
• Acompanhar casos conforme o plano do projeto.
• Coletar e relatar problemas de qualidade aos membros seniores da equipe.

Conhecimentos

Organização

Atenção aos detalhes

Trabalho em equipe

Independência

Formação académica

Bacharelado em ciências da vida

Descrição da oferta de emprego

Job Overview

As a Regulatory Reporting Specialist, you will be involved in submitting safety reports to regulatory authorities.

Review, assess, and process safety data and information received from various sources. Distribute reports/data to internal and external third parties following applicable regulations, Standard Operating Procedures (SOPs), and internal guidelines under the guidance and support of senior operation team members.

Essential Functions

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.

Qualifications

• Bachelor's degree in life sciences
• Languages: Advanced level of English
• 2-3 years of experience in pharmacovigilance activities (mandatory) Specifically in regulatory reporting, will be highly valued.
• 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.

Work modality:

100% home-based

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com