Trilingual Pharmacovigilance Regulatory Reporting Specialist

About the role

The Regulatory Reporting Specialist will support the submission of safety reports to health authorities, ensuring that all pharmacovigilance data is processed accurately and in compliance with global regulations. This position requires fluency in English, Spanish, and Portuguese and operates fully remotely.

Key responsibilities

• Process safety data according to applicable regulations, guidelines, SOPs, and project requirements.
• Prepare and submit regulatory safety reports to authorities.
• Distribute reports and data to internal and external stakeholders while adhering to quality, productivity, and delivery standards.
• Track case progress against project plans and identify quality issues.
• Liaise with functional team members and healthcare professionals to resolve project‑related issues.
• Participate in project team meetings and provide feedback on challenges and successes.

Required profile

• Bachelor’s degree in life sciences.
• Advanced proficiency in English, Spanish, and Portuguese.
• Minimum 1 year of experience in pharmacovigilance, preferably in regulatory reporting.
• Experience with Argus or similar safety databases is desirable.
• Strong knowledge of medical terminology and safety data handling.
• Excellent organizational skills and attention to detail.

Required skills

• Argus (pharmacovigilance safety database).

What we offer

• 100% home‑based work environment.
• Opportunity to work with a global leader in clinical research and healthcare intelligence.
• Professional development within a collaborative, multilingual team.