Sr Associate Global Safety

Há 16 horas

Sao Paulo, Brasil Amgen Tempo inteiro

Career CategorySafety**Job Description**:Sr Associate Global SafetyAmgen 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..

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