Operations Specialist 1

ARG IQVIA RDS Argentina SRL; Buenos Aires; A distancia; USD 45.000 - 65.000; Jornada completa

Descripción de la vacante

A leading global provider of clinical research services is seeking a Regulatory Reporting Specialist to work from home. The ideal candidate will have a Bachelor's degree in life sciences and 1-2 years of experience in pharmacovigilance, specifically in Regulatory Submissions. Responsibilities include processing safety data, ensuring compliance, and collaborating with teams. Offers private medical insurance and internet allowance.

Servicios

Private Medical Insurance

Internet allowance

Employee Assistance Program

Gympass

Additional week of vacations

100% work from home

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.
• Ensure compliance with quality and delivery standards.
• Track cases as applicable to the project plan.
• Identify and report quality problems to senior team members.
• Liaise with different functional team members on issues.

Conocimientos

Advanced level of English

Strong organizational skills

Attention to detail

Ability to work independently

Team collaboration

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.
• Advanced level of English.
• 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!

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com