Regulatory Submissions Specialist

hace 4 semanas


Municipio de Esquel, Argentina IQVIA A tiempo completo

Overview Regulatory Submissions Specialist (with Portuguese) This role requires working on National Holidays and weekends as needed. Responsibilities Process safety data according to applicable regulations, guidelines, SOPs, and project requirements. Review, assess, and process safety data and information from various sources. Distribute reports/data to internal and external third parties following applicable regulations, SOPs, and internal guidelines under the guidance of senior operations team members. 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 (mandatory) Advanced level of English (mandatory) Advanced level of Portuguese (mandatory) 1-2 years of experience in pharmacovigilance activities; ideal profile includes regulatory submissions experience. Good knowledge of medical terminology and safety databases (ARGUS). Strong organizational skills, attention to detail, and ability to work independently and as part of a team. Work modality 100% home-based Will require to work some National Holidays Will require to work alternate weekends What we offer Private Medical Insurance Internet allowance Employee Assistance Program: free and confidential support available 24/7 for you and your family such as counselling, referrals and work-life resources Gympass Additional week of vacations 100% work from home IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. Learn more at #J-18808-Ljbffr



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