Pharmacovigilance Regulatory Reporting (Trilingual)

IQVIA LLC; São Paulo; Remote; BRL 60,000 - 100,000; Full time

Job summary

IQVIA is seeking a Regulatory Reporting Specialist to submit safety reports to regulatory authorities and process safety data from multiple sources. You will distribute reports to internal teams and external parties under SOPs and guidance from senior staff.

This 100% home-based role requires fluency in English, Spanish, and Portuguese, a life sciences degree, and at least one year of pharmacovigilance experience; Argus knowledge is a plus.

Qualifications

• Bachelor's degree in life sciences.
• Advanced level of English, Spanish and Portuguese.
• 1 year of pharmacovigilance experience (mandatory). Specifically in regulatory reporting is valued.

Responsibilities

• Process safety data according to regulations, SOPs, and project requirements.
• Track cases per project plan and report quality issues to senior team members.
• Liaise with functional teams and healthcare professionals to resolve project-related issues.

Skills

English

Spanish

Portuguese

Education

Bachelor's degree in life sciences

Tools

Argus

Job description

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.

Work Modality

100% home-based.

Company Information

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. 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. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.