Regulatory Submissions Specialist

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. Review, assess, and process safety data and information received from various sources. 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 Pharmacovigilance Specialist with English and Portuguese Advanced (Fixed-term, 6 Months) IQVIA Buenos Aires, Argentina | Full time | Home-based | R This role is ideal if you're looking to start your career in pharmacovigilance, it's not required that you have experience in the field, but it will be a plus Fixed‑term role, for 6 months English and Portuguese Regulatory Affairs Specialist AbbVie Company Description Major Responsibilities Provides strategic direction to support the development of compliant and competitive Regulatory programs; Manages the preparation and review of regulatory submissions consistent within Regulatory requirements and guidelines to… Site Activation Specialist Home-based in Argentina with at Least 2 Years of Experience Syneos - Clinical and Corporate - Prod DescriptionSite Activation Specialist Home-Based in Argentina with at least 2 years of experienceSyneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and… Specialist, Marketing (South Cone Region) PTC THERAPEUTICS Job Description Summary:Job Description:Hybrid position (Office Location: Vicente López, Buenos Aires)About the PTC TherapeuticsFounded in 1998, PTC Therapeutics is a global commercial, diversified biopharmaceutical company. Our team is deeply committed to a unifying… Public Affairs & Advocacy Specialist Sanofi Public Affairs & Advocacy SpecialistBuenos Aires, ArgentinaSanofi is a leading and innovative healthcare company, structured in 4 global business units: General Medicines, Specialty Care, Vaccines, and Consumer Healthcare. Sanofi discovers, develops, and distributes… Kenvue Kenvue is currently recruiting for a:Analista de Asuntos Regulatorios Cono SurWhat we doAt Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house of iconic brands - including NEUTROGENA®,… #J-18808-Ljbffr