Regulatory Submissions Specialist

hace 3 días


Buenos Aires, Argentina Parexel A tiempo completo

Regulatory Submissions Specialist (with Portuguese) IQVIA This role will require special working days as National Holidays and weekends. Job Overview As a Regulatory Reporting Specialist, you will be involved in submitting safety reports to regulatory authorities. You will review, assess, and process safety data and information received from various sources. You will distribute reports/data to internal and external third parties following applicable regulations, Standard Operating Procedures (SOPs), and internal guidelines under the guidance and support of senior operation team members. Essential Functions Process safety data according to applicable regulations, guidelines, SOPs, and project requirements. Ensure compliance with quality, productivity, and delivery standards per project requirements. 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 will have specific experience in Regulatory Submissions. Good knowledge of medical terminology and applicable 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 #J-18808-Ljbffr


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