Pharmacovigilance Regulatory Reporting (Trilingual)

About the role

The Regulatory Reporting Specialist will submit safety reports to regulatory authorities, process safety data, and ensure compliance with applicable regulations and SOPs. This is a fully remote, home‑based position requiring fluency in English, Spanish, and Portuguese.

Key responsibilities

• Process safety data according to regulations, guidelines, SOPs, and project requirements.
• Distribute reports and data to internal and external parties while maintaining quality, productivity, and delivery standards.
• Track cases, identify quality issues, and report them to senior team members.
• Liaise with functional teams and healthcare professionals to resolve project‑related issues.
• Participate in project team meetings and provide feedback to the operations manager.

Required profile

• Bachelor's degree in life sciences.
• Advanced proficiency in English, Spanish and Portuguese.
• At least 1 year of experience in pharmacovigilance, specifically regulatory reporting.
• Strong organizational skills, attention to detail, and ability to work independently and in a team.

Required skills

• Experience with Argus safety database (desired).
• Good knowledge of medical terminology and safety databases.