Gerente de Projetos – Rio de Janeiro

Então, confira a oportunidade abaixo e venha fazer parte do nosso time Haleon!

Gerente de Projetos (Farmacovigilância)

O Líder de Operações e Suporte apoia as equipes de Segurança do Consumidor, Desenvolvimento Clínico e Assuntos Médicos com gerenciamento operacional e uso dos sistemas clínicos e de segurança da Haleon para realizar as funções de negócios das respectivas funções. A função requer o envolvimento com grupos de trabalho multifuncionais relevantes e a gestão das principais partes interessadas.

O líder de operações e suporte é responsável por atuar como um canal para os usuários finais do sistema e colegas técnicos para permitir o desenvolvimento e o aprimoramento de soluções nos domínios de negócios atribuídos. As principais atividades incluem gerenciamento de projetos, habilitação de acesso a dados, métricas, relatórios e análises, design de painel e interface, mapeamento de processos e suporte de treinamento.

Principais responsabilidades:  

• Fornecer suporte de consulta abrangente para parceiros de negócios
• Coletar, manter e priorizar os requisitos do usuário para aplicações e soluções aplicáveis.
• Desenvolvimento e gerenciamento de planos de acesso ao sistema e atividades de supervisão de contas de usuários
• Contribuição para o planeamento da Continuidade de Negócios e execução das atividades do BCP
• Suporte de usuários finais que necessitam de assistência e/ou treinamento de funcionalidade/capacidade
• Trabalhar em estreita colaboração com proprietários de negócios e partes interessadas para fornecer processos e soluções que apoiem os processos de negócios e cumpram os requisitos regulamentares.Ensuring GxP requirements and a prontidão para inspeção seja mantida e atualizada. Apoiar a preparação para Auditoria/Avaliação/Inspeção e liderar ou participar de auditorias internas e/ou inspeções externas conforme necessário.
• Criar o clima para a melhoria contínua da forma de trabalhar e otimizar processos com a solução mais adequada considerando qualidade, custo e necessidades de negócio.
• Gerenciar a preparação, manutenção e execução de scripts de teste de aceitação do usuário conforme necessário. Identifique oportunidades para testar eficiências e confirme se os critérios de aceitação foram atendidos do ponto de vista comercial.
• Fornecer informações para o desenvolvimento, aprimoramento, implementação e manutenção de todos os padrões escritos e conteúdos de treinamento impactados.
• Supervisão da equipe aplicável do fornecedor/contrato para projetos e implementações relevantes.
• Planejar, monitorar e gerenciar projetos desde o início até a conclusão. Lidera ou coordena o planejamento do projeto, recursos, relatórios e solução de problemas para garantir que as entregas atendam aos requisitos e cronogramas.Working in close collaboration with Operations and Support colleagues to provide input on impact of enhancements and change requests across all systems, processes and downstream outputs.
• Responsável pela resolução e escalonamento de incidentes aplicáveis, agindo de acordo com as solicitações dos usuários em colaboração com colegas técnicos, conforme necessário.
• Contribuir nas discussões com as partes interessadas do negócio para compreender os requisitos do negócio, melhorias e roteiro do produto, apoiar a documentação de processos internos, requisitos do usuário, padrões escritos, comunicações e desenvolvimento e conteúdo de treinamento.
• Apoiar auditorias internas e externas e solicitações de inspeção de HA e LP conforme necessário.
• Fornecer orientação e suporte ao usuário, incluindo tarefas de gerenciamento de acesso e incidentes.
• Responsável pela implantação de regras de relatórios acelerados e configuração relevante de perfil de organização e transmissão.
• Suporta conexão, configuração e testes de gateway E2B com parceiros externos.
• Fornecer consultoria e suporte para solução de problemas de erros e falhas do sistema, como falhas de transmissão, confirmações negativas e outros problemas de envio.
• Fornecer informações como PME para o desenvolvimento, aprimoramento, implementação e manutenção de todos os padrões escritos impactados e conteúdo de treinamento necessário.

Suas Qualificações:

• Licenciatura em ciências da vida ou tecnologia de informação ou outra área relacionada.
• 7 anos de conhecimento e experiência na indústria farmacêutica e/ou indústria de bens de consumo com um mínimo de 5 anos em Farmacovigilância.
• Domínio de experiência em configuração de Sistema de Segurança de Medicamentos, preferencialmente sistema Veeva Safety Vault.Experience with sistemas de gestão de documentos validados.
• Experiência com suporte a configurações de sistemas de farmacovigilância e segurança e conexões e submissões E2B R2/R3.
• Compreensão comprovada dos processos de segurança/farmacovigilância/pesquisa clínica e das principais regulamentações de agências como FDA, EMA, PMDA, MFDS e NMPA, ICH GVP e GxP em relação à validação e documentação de sistemas.
• Histórico de sucesso em melhoria contínua, práticas de trabalho inovadoras e promoção de mudanças.
• Experiência de trabalho com metodologia de entrega Agile com compreensão do ciclo de vida de desenvolvimento do sistema é um diferencial.
• Conhecimento de backlog JIRA e gerenciamento de requisitos.

Se sente que esse é seu próximo passo de carreira, inscreva-se até 25/10/2024! 

Diversidade, Equidade e Inclusão 

Na Haleon, vamos além das expectativas e impulsionamos uma cultura em que fazemos o que mais importa. Promovemos um ambiente onde a diversidade seja celebrada, a equidade seja praticada e a inclusão seja vivenciada.

Nosso compromisso é humanizar as relações, respeitando à individualidade e garantindo que cada colaborador sinta-se valorizado, incluído e parte essencial de nossa comunidade.

#CareToJoinUs #HaleonCarreiras #Oportunidade #HaleonBrasil

In English

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands – including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum – through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question.

With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.

This is an exciting time to join us and help shape the future. It’s an opportunity to be part of something special.

About The Role

The Operations and Support Lead supports the Consumer Safety, Clinical Development and Medical Affairs teams with operational management and use of Haleon’s safety and clinical systems to carry out the business functions of the respective functions. The role requires engagement with relevant cross-functional working groups and management of key stakeholders.

The Operations & Support Lead is responsible to act as a conduit to system end users and Tech colleagues to enable development and enhancement of solutions that the assigned business domains. Key activities include project management, data access enablement, metrics, reporting and analysis, dashboard and interface design, process mapping and training support.

Key Responsibilities

The Operations & Support Lead will be accountable for:

• Providing complex query support for business partners
• Collecting, maintaining and prioritizing user requirements for applicable applications and solutions
• Development and management of System Access Plans and user account oversight activities
• Contribution to Business Continuity planning and execution of BCP activities
• Support of end users that require functionality/capability assistance and/or training
• Working in close collaboration with business owners and stakeholders to provide processes and solutions that support business processes and fulfil regulatory requirements.
• Ensuring GxP requirements and inspection readiness are maintained and current. Supporting Audit/Assessment/Inspection readiness and leading or participating in internal audits and/or external inspections as needed.
• Creating the climate for continuous improvement way of working and optimize processes with the most appropriate solution considering quality, cost and business needs.
• Managing the preparation, maintenance and execution of user acceptance test scripts as required. Identify opportunities for testing efficiencies and confirm that acceptance criteria have been met from the business perspective.
• Providing input for the development, enhancement, implementation and maintenance of all impacted written standards and training content.
• Oversight of applicable vendor/contract staff for relevant projects and implementations.
• Plan, monitors and manages projects from initiation through completion. Leads or coordinates project planning, resourcing, reporting and troubleshooting to ensure deliverables meet requirements and timelines.
• Working in close collaboration with Operations and Support colleagues to provide input on impact of enhancements and change requests across all systems, processes and downstream outputs.
• Accountable for resolving and escalating applicable incidents, acting upon user requests in collaboration with Tech colleagues as necessary.
• Contribute to discussions with business stakeholders to understand business requirements, enhancements, and product roadmap, support the documentation of internal processes, user requirements, written standards, communications and training development and content.
• Support internal and external audits and HA and LP inspection requests as needed.
• Provide user guidance and support including access and incident management tasks.
• Responsible for deployment of expedited reporting rules and relevant organization and transmission profile configuration.
• Support E2B gateway connection, configuration and testing with external partners.
• Provide consultation and troubleshooting support for system errors and failures such as transmission failures, negative acknowledgements and other submission problems.
• Provide input as SME for the development, enhancement, implementation and maintenance of all impacted written standards and required training content.

Qualifications And Skills Essential

• Bachelor’s degree in life sciences or information technology or other related area.
• 7 years pharmaceutical industry and/or consumer goods industry knowledge and experience with minimum 5 years in Pharmacovigilance.
• Mastery experience in Drug Safety System configuration, preferably Veeva Safety Vault system.
• Experience with validated document management systems.
• Experience with supporting pharmacovigilance and safety system configurations and E2B R2/R3 connection and submissions.
• Proven understanding of the safety/pharmacovigilance/clinical research processes and major agency regulations like FDA, EMA, PMDA, MFDS and NMPA, ICH GVP and GxP regarding systems validation and documentation.
• Track record of success in continuous improvement, innovative work practices and driving change.
• Experience of working within Agile delivery methodology with an understanding of the system development life cycle a plus.
• Knowledge of JIRA backlog and requirement management.

Preferred

• Technical background and computer proficiency in a variety of pharmacovigilance, clinical or related systems, reporting capabilities and familiarity with MS O365.
• Excellent interpersonal and written and verbal communications skills with a proven ability to interact well with all levels.
• Ability to identify opportunities for process and compliance improvements.
• Enhanced customer service orientation and ability to communicate professionally to diverse cross-functional non-technical and technical audiences.
• Experience in work requiring attention to detail and excellent follow-up.
• Self-motivated, able to resolve issues with cross-functional teams with minimal supervision.

If you feel this is your next career step, apply by 25/10/2022!

Diversity, Equity and Inclusion

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.

We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Care to join us. Find out what life at Haleon is really like www.haleon.com/careers/

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.

Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.