Sr Associate Global Safety

Há 4 dias

Sao Paulo, Brasil Amgen Tempo inteiro

Career Category

Safety

**Job Description**:
Sr Associate Global Safety

Amgen local pharmacovigilance team is responsible for maintaining compliance for the activities under its responsibility. To this end, there is interaction with local teams in the medical, regulatory, commercial and global areas, in addition to service providers and commercial partners.

**Responsibilities**:
This role demonstrates a good working knowledge of policies, procedures and systems and practical understanding of legislation which applies to safety practices locally. Effective operation performance is based on ability to conduct core operational activities based on competent knowledge of safety terminology, database use and tools needed to handle and submit individual and periodic safety reports. The role also requires the ability to develop a broad understanding of how local safety supports both Amgen Global Patient Safety and the local business.

The major activities for the role are:
- To conduct core safety activities including data collection, processing, distribution and regulatory submission within the relevant local country/countries, based on appropriate training and assigned roles within the safety database and related systems.- To maintain compliance with local legislation and Company policies.- To assist Safety Country Lead to provide full range of safety activities to support the local business, including safety training and participation in local medical teams providing safety expertise and information.- The ability to identify, priorities and escalate safety issues is also very important.- To assist Safety Country Lead in the oversight of clinical trial activities related to Safety that are performed in the region under responsibility.- To be the back-up of Argentinean Safety Associate.- To perform the role of Local Safety Responsible Person Deputy in Brazil.

Basic Qualifications- Bachelor's degree in healthcare (pharmacy or nursing)- Advanced English- Differential Spanish- Microsoft Office - literacy- Safety database literacy (differential Argus)

Skills and Requirements- 4+ years’ experience pharmacovigilance- 2 years of experience in a coordination position, preferably in biotechnology companies or pharmaceutical companies- Practical understanding of legislation which applies to safety practices locally- Computer literacy with competent knowledge of safety database use- Knowledge of local data privacy requirements- Understanding of relevant medical & safety terminology- Ability to identify, prioritize and escalate safety issues- Problem solving abilities- Confident handling of core operational safety activities, when trained.

Amgen does not discriminate in its employment opportunities on the basis of sex, race, color, age, national origin, political or religious ideas, gender, sexual orientation, gender identity, level and type of disability, ethnic origin, or any other category protected by law.

.

  • Associate/senior Associate/associate Consultant

    1 semana atrás

    Sao Paulo, Brasil Eli Lilly Tempo inteiro

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...

  • Senior Drug Safety Associate

    4 semanas atrás

    Sao Paulo, Brasil Icon plc Tempo inteiro

    ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.With our patients at the centre of all that we do, we help to accelerate the development...

  • Road Safety Sr. Program Manager

    Há 4 dias

    São Paulo, Brasil Uber Tempo inteiro

    **About the Role** Uber is looking for a strategic, analytical, and highly organized Road Safety Program Manager to join our Central Safety team. In this role, you will lead the development and execution of global safety programs, policies, and risk mitigation strategies, with a particular focus on two-wheeled vehicle safety across our Mobility and Delivery...

  • Safety Operations Manager

    4 semanas atrás

    São Paulo, Brasil DiDi Global Tempo inteiro

    Company Overview:If you see technology as a way to smooth your path in life, our team does too: Your Path, Our Journey.We believe in technology that connects talented people who embrace diversity to create and share paths we don't even know about (yet!). We work to generate value not only for our users but, above all, for the communities we serve and for...

  • Sr. Associate

    2 semanas atrás

    São Paulo, Brasil Credit Saison Brazil Tempo inteiro

    We are actively seeking a Sr. Associate in Regulatory Reporting and Financial Operations to be the driving force behind scaling our company's FinOps structure and guaranteeing the seamless reconciliation of complex financial products. This highly engaged professional will hold a unique dual mandate, combining strategic execution with operational delivery.The...

  • Sr. Associate

    1 semana atrás

    São Paulo, Brasil Credit Saison Brazil Tempo inteiro

    We are actively seeking a Sr. Associate in Regulatory Reporting and Financial Operations to be the driving force behind scaling our company's FinOps structure and guaranteeing the seamless reconciliation of complex financial products. This highly engaged professional will hold a unique dual mandate, combining strategic execution with operational delivery....

  • Associate, Global Macroeconomics

    1 semana atrás

    Sao Paulo, Brasil Eurasia Group Tempo inteiro

    **About Eurasia Group** Eurasia Group is the world's leading global political risk research and consulting firm. By providing information and insight on how political developments move markets, we help clients anticipate and respond to instability and opportunities everywhere they invest or do business. Our expertise includes developed and developing...

  • Senior Specialist, Global Safety and Security

    4 semanas atrás

    São Paulo, Brasil Tech Economy Tempo inteiro

    Senior Specialist, Global Safety and Security As a member of Bain's Global Safety & Security team, you’ll be part of a small, high-impact group that partners across Bain offices and functions worldwide. This team supports our people and business by delivering programs and support that enable us to operate safely, respond to global events, and foster a...

  • Pharmacovigilance Associate

    4 semanas atrás

    São Paulo, Brasil ICON Plc Tempo inteiro

    Pharmacovigilance AssociateICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Pharmacovigilance Associate to join our...

  • Desenvolvedor Java Sr

    4 semanas atrás

    Sao Paulo, Brasil Global TI Tempo inteiro

    A GLOBAL TI, desde 2001, vem atuando no mercado de Tecnologia da Informação prestando serviços de forma singular e personalizada para clientes de médio e grande porte dos mais variados segmentos.Venha fazer parte desta trajetória de sucesso, buscamos profissionais com o perfil abaixo:Desenvolvedor JAVA SRJava 6 e/ou 8...