Pharmacovigilance Regulatory Reporting (Trilingual)

Iqvia; Madrid; Remote; EUR 28,000 - 40,000; Full time

Benefits offered by this job

100% home-based

Remote work

Flexible schedule

Collaborative tools

Job summary

Iqvia seeks a Pharmacovigilance Regulatory Reporting specialist to process safety data for regulatory submissions and ensure SOP and project compliance. You will coordinate reporting to regulatory authorities and internal partners while working with cross-functional teams.

This remote, multilingual role supports pharmacovigilance activities in English, Spanish, and Portuguese, offering meaningful impact on patient safety within a global network and opportunities to collaborate with healthcare

Qualifications

• Bachelor's degree in life sciences.
• Languages: Advanced English, Spanish, and Portuguese.
• 1 year of pharmacovigilance experience, regulatory reporting.
• Experience with Argus is desirable.
• Strong medical terminology and safety database knowledge.
• Excellent organizational skills; ability to work independently and in a team.

Responsibilities

• Process safety data to support regulatory submissions.
• Coordinate reporting of safety information to regulatory authorities and internal/external partners.
• Attend meetings and provide feedback to operations management.
• Track cases aligned with the project plan.
• Liaise with cross-functional teams and healthcare professionals to resolve issues.

Skills

English

Spanish

Portuguese

Pharmacovigilance

Argus (desirable)

Medical terminology

Organizational skills

Education

Bachelor's degree in life sciences

Tools

Argus

Job description

Experteer Overview In this role you will process safety data to support regulatory submissions and ensure compliance with SOPs and project requirements. You will coordinate reporting of safety information to regulatory authorities and internal/external partners, under guidance from senior team members. You will work across functions and healthcare professionals to address project challenges, attending meetings and providing feedback. The position is fully remote, leveraging multilingual capabilities to support pharmacovigilance activities in English, Spanish, and Portuguese. This role offers a meaningful impact on patient safety and regulatory compliance within a global team.

Compensaciones / Beneficios

• Process safety data per regulations, guidelines, SOPs, and project needs
• Ensure quality, productivity, and on-time delivery per project requirements
• Track cases aligned with the project plan
• Identify and report quality problems to senior team members
• Liaise with cross-functional teams and healthcare professionals to resolve issues
• Attend project team meetings and provide feedback to operations management

Responsabilidades

• Bachelor's degree in life sciences
• Languages: Advanced English, Spanish, and Portuguese
• 1 year of pharmacovigilance experience, specifically regulatory reporting
• Experience with Argus is desirable
• Strong medical terminology knowledge and safety databases
• Excellent organizational skills, attention to detail, ability to work independently and in a team

Requisitos principales

• 100% home-based
• remote work
• flexible work arrangement
• collaborative tools

Pharmacovigilance Regulatory Reporting (Trilingual)

Madrid, ES