Regulatory Submissions Specialist (with Portuguese)

Parexel; A distancia; ARS 6.500.000 - 9.750.000; Jornada completa

Descripción de la vacante

A global health services company is seeking a Regulatory Submissions Specialist with advanced English and Portuguese skills for a home-based role in Buenos Aires. In this position, you will be responsible for submitting safety reports, ensuring compliance with applicable regulations, and liaising with various teams. The ideal candidate will have a Bachelor's degree in life sciences and 1-2 years of experience in pharmacovigilance. Benefits include private medical insurance, internet allowance, and extra vacation weeks.

Servicios

Private Medical Insurance

Internet allowance

Employee Assistance Program

Gympass

Additional week of vacations

100% work from home

Formación

• Bachelor's degree in life sciences is mandatory.
• Advanced English and Portuguese language skills are required.
• 1-2 years of experience in pharmacovigilance activities.
• Specific experience in Regulatory Submissions is ideal.

Responsabilidades

• Process safety data according to relevant regulations and SOPs.
• Ensure compliance with quality and project delivery standards.
• Track cases as applicable to the project plan.
• Report quality issues to senior team members.
• Liaise with different functional teams for project-related issues.
• Attend project team meetings and provide feedback.

Conocimientos

Regulatory submissions experience

Advanced English

Advanced Portuguese

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. 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!