Pharmacovigilance regulatory reporting specialist – São Paulo/SP [remoto]

Responsabilidades

• 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.

Requisitos

• Bachelor’s degree in life sciences.
• Languages: Advanced level of English.
• 2-3 years of experience in pharmacovigilance activities (mandatory). Specifically in regulatory reporting, will be highly valued.
• Previous experience working with Argus is required.
• 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.

Marcado como: Análises, Farmacologia, Saúde