Regulatory Submissions Specialist (with Portuguese)

ARG IQVIA RDS Argentina SRL; Ciudad de México; A distancia; MXN 200,000 - 400,000; Jornada completa

Descripción de la vacante

A leading healthcare firm is looking for a Regulatory Reporting Specialist to submit safety reports to regulatory authorities. The role requires a Bachelor's degree in life sciences, advanced English and Portuguese, and 1-2 years of relevant experience. Responsibilities include processing safety data, ensuring compliance with regulations, and collaborating with team members. This is a fully remote position with special working days during national holidays and weekends.

Servicios

Private Medical Insurance

Internet allowance

Employee Assistance Program

Gympass

Additional week of vacations

Formación

• 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.

Responsabilidades

• Process safety data according to applicable regulations and project requirements.
• Ensure compliance with quality and delivery standards.
• Track cases as applicable to the project plan.

Conocimientos

Advanced English

Advanced Portuguese

Attention to detail

Organizational skills

Educación

Bachelor's degree in life-sciences

Herramientas

ARGUS

Descripción del empleo

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!