Analista de Farmacovigilância Sr (LatAm)

Galderma Distribuidora do Brasil Ltda; São Paulo; On-site; BRL 90,000 - 130,000; Full time

Job summary

A Galderma Distribuidora do Brasil Ltda busca profissional em farmacovigilância para atuar na gestão de qualidade, conformidade regulatória e relacionamento com autoridades de saúde na América Latina. O papel envolve coordenação de processos, treinamentos e apoio a auditorias.

O candidato ideal possui formação na área da saúde, fluência em inglês e espanhol, excelentes habilidades de comunicação e experiência em farmacovigilância. Local de atuação em SP e regime presencial.

Qualifications

• Fluência em Inglês e Espanhol (obrigatório).
• Fortes habilidades de comunicação verbal e escrita.
• Fortes habilidades de relacionamento, resolução de problemas e negociação.

Responsibilities

• Gerenciar a qualidade de todos os procedimentos, implementar auditorias e projetos de melhoria de farmacovigilância na América Latina.
• Atender solicitações de autoridades de saúde sobre informações de segurança, disponíveis 24/7 dentro dos prazos legais.
• Conduzir ações de vigilância pós-comercialização, revisando e encaminhando relatos de eventos adversos ao Global Pharmacovigilance.
• Desenvolver, revisar e aprovar procedimentos de farmacovigilância para LATAM e mantê-los atualizados.
• Treinar colaboradores da Galderma Brasil e LATAM em farmacovigilância, conforme cronograma de treinamentos presenciais e online.
• Preparar e revisar relatórios periódicos de farmacovigilância, planos de farmacovigilância e planos de mitigação de risco.
• Notificar autoridades de saúde na América Latina com relatórios de eventos adversos.
• Garantir conformidade com GMP de farmacovigilância e rastreabilidade documental.
• Participar de reuniões com entidades nacionais e autoridades para alinhar ações de mercado.
• Controlar métricas de conformidade e qualidade em farmacovigilância.

Skills

Inglês fluente

Espanhol fluente

Boas habilidades de comunicação

Relacionamento e negociação

Education

Formação na área da saúde

Job description

Com um legado único em dermatologia e décadas de inovação de ponta, a Galderma é a líder emergente na categoria de dermatologia, presente em aproximadamente 90 países. Oferecemos um portfólio inovador baseado na ciência de marcas premium e serviços que abrangem todo o espectro do mercado de dermatologia em rápido crescimento através de Estética Injetável, Cuidados Dermatológicos e Dermatologia Terapêutica. Desde a nossa fundação em 1981, dedicamos nossa atenção e paixão ao maior órgão do corpo humano - a pele - atendendo às necessidades individuais de consumidores e pacientes com resultados superiores em parceria com profissionais de saúde. Porque entendemos que a pele em que estamos molda nossas vidas, estamos avançando na dermatologia para cada história de pele. Procuramos pessoas que se concentrem em obter resultados, abracem a aprendizagem e tragam uma energia positiva. Eles devem combinar iniciativa com um senso de trabalho em equipe e colaboração. Acima de tudo, devem estar apaixonados por fazer algo significativo para os consumidores, pacientes e profissionais de saúde que atendemos todos os dias. Nosso objetivo é capacitar cada funcionário e promover seu crescimento pessoal, garantindo ao mesmo tempo que as necessidades comerciais sejam atendidas agora e no futuro. Em toda a nossa empresa, abraçamos a diversidade e respeitamos a dignidade, a privacidade e os direitos pessoais de cada funcionário. Na Galderma, damos ativamente às nossas equipes motivos para acreditar em nossa ousada ambição de nos tornarmos a principal empresa de dermatologia do mundo. Com a gente, você tem a oportunidade definitiva de adquirir novas e desafiadoras experiências de trabalho e criar um impacto direto incomparável.

About Galderma

Galderma is the leading company in the category dedicated to dermatology, present in approximately 90 countries. We provide an innovative, science-based portfolio of premium brands and services that span the full spectrum of the rapidly growing dermatology market, through Injectable Aesthetics, Dermocosmetics and Therapeutic Dermatology. Since our founding in 1981, we've dedicated our focus and passion to the largest organ in the human body - the skin - meeting the individual needs of consumers and patients with superior outcomes in partnership with healthcare professionals. We're advancing dermatology for every skin story because we understand that the skin we're in shapes our life stories.

Work at Galderma

At Galderma, you will have the ultimate opportunity to gain life-changing work experiences. We are committed to meeting the individual needs of consumers and patients, with superior outcomes, in partnership with healthcare professionals. At our company, we embrace differences and respect diversity, privacy and the personal rights of every employee. We are committed to keeping our workplace respectful and inclusive. We are proud of our dedication to diversity and inclusion and want to ensure that the people we do business with know, share and respect our standards. If you seek to put your ideas into practice, make a difference and exercise your purpose, your place is here.

Opportunity - Main Responsibilities

• Ensure quality management of all procedures, implementation of the audit findings and Pharmacovigilance improvement projects in Latin America, participating in the constant mapping of the implemented processes and review control of the documents, and direct line of communication with the responsible by Pharmacovigilance of Europe (EU-QPPV), aiming the continuity of compliance with Latin America regulations, local, regional and international legislations and global pharmacovigilance policies.
• Ensure that any request from the Health Authorities regarding safety information necessary to assess risk-benefit for Galderma products, being available 24/7, in order to send complete answer and in accordance with regulatory deadlines in current legislation.
• Operate the vigilance routine actions of Galderma Latin America post-marketing surveillance, through review and submit to Global Pharmacovigilance (Corporate) the adverse event reports, in order to ensure the compliance with national, regional, global, legal and contractual rules.
• Implement, elaborate, review and approve the procedures related to Latin America Pharmacovigilance and keep them updated, through periodic search of pharmacovigilance regulations of Latin American and global procedures, aiming the notifications quality of adverse events with Galderma products in accordance with current legislation and related good practice guides.
• Review and ensure the implementation of pharmacovigilance training post-marketing Surveillance to all employees of Galderma Brazil, Latin America LSOs and Regional PV Staff, through periodic Pharmacovigilance actions according to the presential and conference call/web meeting scheduled trainings, in order that all employees of Galderma America Latin be able to identify and report any adverse events related to Galderma products.
• Elaborate and review the documentation for periodic Pharmacovigilance reports, Pharmacovigilance Plan and Risk Minimization Plan, when necessary, in order to ensure the monitoring of Galderma products safety profile.
• Notify and review the spontaneous reports of drug adverse events to all Health Authorities in Latin America with Galderma Affiliate, through an electronic form on the regulatory agency website, in order to comply the current legislation.
• Ensure that all files related to the Pharmacovigilance and Customer Service areas will be manage following Good Practice of Pharmacovigilance through periodic and continuous document reviews, in order to guarantee traceability according to the current legislation.
• Participate in meetings with national entities, public authorities, organizations and associations of Pharmacovigilance and Customer Service, aiming alignment with market actions and anticipation of regulatory and legal needs.
• Elaborate and control of compliance metrics in Pharmacovigilance, through KPIs management, aiming the improvement of quality processes.
• Support the execution of corporate audits at Galderma Affiliates in Latin America Countries and execute audits at Distributors under LATAM Regional responsibilities, aiming ensure the Good Pharmacovigilance Practices.

Knowledge and Skills

• Fluent in English and Spanish (mandatory)
• Strong verbal and written communication skills
• Strong relationship, problem-solving & negotiating skills.

Work Experience

• Between 5 and 7 years in Pharmacovigilance Conduct of Pharmacovigilance legislation, Technovigilance, NOTIVISA and CVS

Education

• Professional education in the area of health with experience in Pharmacovigilance.

Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we're in shapes our lives, we are advancing dermatology for every skin story.

For more information go to www.galderma.com/careers