Pharmacovigilance Regulatory Reporting (Trilingual)

Pro Selection Capital Humano; Buenos Aires; À distance; ARS 59 210 000 - 93 044 000; Plein temps

Avantages offerts par ce poste

Fully remote

Résumé du poste

IQVIA is seeking a Regulatory Reporting Specialist for pharmacovigilance activities. This role requires reviewing safety data, processing reports, and distributing information to internal and external parties under SOPs and guidance from the operations team.

The position is 100% remote and demands fluency in English, Spanish, and Portuguese. The candidate will join a global provider of clinical research services with a focus on integrity and high-quality data handling, contributing to safety

Qualifications

• Bachelor's degree in life sciences.
• Advanced English, Spanish and Portuguese.
• 1 year of pharmacovigilance experience (mandatory).
• Experience with regulatory reporting is highly valued.
• Experience with Argus is desirable.
• Good knowledge of medical terminology and safety databases.
• Strong organizational skills and ability to work independently and in a team.

Responsabilités

• Process safety data according to regulations, SOPs and project requirements.
• Ensure compliance with quality, productivity and delivery standards.
• Track cases according to the project plan.
• Identify and report quality problems to senior team members.
• Liaise with health care professionals to address project-related issues.
• Attend project team meetings and provide feedback to the operations manager.

Connaissances

English (advanced)

Spanish (advanced)

Portuguese (advanced)

Formation

Bachelor's degree in life sciences

Outils

Argus

Description du poste

Pharmacovigilance Regulatory Reporting (Trilingual)

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. This is a trilingual role requiring fluency in English, Spanish, and Portuguese.

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
• Languages: Advanced level of English, Spanish and Portuguese.
• 1 year of experience in pharmacovigilance activities (mandatory) Specifically in regulatory reporting, will be highly valued.
• Previous experience working with Argus is desirable.
• Good knowledge of medical terminology and applicable safety databases.
• Strong organizational skills, attention to detail, and ability to work independently and as part of a team.

100% home-based

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.