Pharmacovigilance Regulatory Reporting Specialist

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Preparing and submitting safety reports to regulatory agencies.

• Evaluating, analyzing, and processing safety data and information from diverse sources.

• Distributing reports and data to both internal and external stakeholders.

• Processing safety information in accordance with relevant regulations, guidelines, SOPs, and project requirements.

• Ensuring adherence to quality, productivity, and delivery standards as outlined in project specifications.

• Monitoring cases as necessary in line with the project plan.

• Identifying and communicating quality issues to senior team members.

• Collaborating with various functional team members and healthcare professionals to resolve project-related concerns.

• Participating in project team meetings and providing insights to the operations manager regarding challenges, issues, or achievements.

⛳️ Requirements

• Bachelor's degree in life sciences.

• Proficient in English at an advanced level.

• 2-3 years of experience in pharmacovigilance activities (mandatory).

• Prior experience with Argus is essential.

• Solid understanding of medical terminology and relevant safety databases.

• Excellent organizational skills, meticulous attention to detail, and the capability to work independently as well as collaboratively in a team.

🏝️ Benefits

• 100% home-based.