Regulatory Submissions Specialist (with Portuguese)

BEON Tech Studio; A distancia; ARS 6.500.000 - 9.750.000; Jornada completa

Descripción de la vacante

A leading healthcare organization in Buenos Aires is seeking a Regulatory Submissions Specialist who will be responsible for submitting safety reports to regulatory authorities. The ideal candidate must have a Bachelor's degree in life-sciences and an advanced level of both English and Portuguese. Responsibilities include reviewing and processing safety data, ensuring compliance with regulations, and tracking cases. This is a full-time, home-based position requiring flexibility to work on national holidays and weekends. Competitive benefits are included.

Servicios

Private Medical Insurance

Internet allowance

Employee Assistance Program

Gympass

Additional week of vacations

Formación

• 1-2 years of experience in pharmacovigilance activities.
• Knowledge of medical terminology and applicable safety databases.

Responsabilidades

• Involved in submitting safety reports to regulatory authorities.
• Review and process safety data from various sources.
• Ensure compliance with quality and delivery standards.

Conocimientos

Advanced level of English

Advanced level of Portuguese

Strong organizational skills

Attention to detail

Educación

Bachelor's degree in life-sciences

Herramientas

ARGUS

Descripción del empleo

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 | R1521456

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

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