Safety & PV Submission Spec I

📋 Description

• Assist with the preparation, design, compilation, and assembly of expedited and periodic safety
• Support the submission of safety reports to regulatory authorities, ethics committees, and clinical
• Maintain accurate tracking records for safety submissions, monitoring submission statuses
• Review safety reporting documentation to help ensure completeness, consistency, and compliance with
• Apply relevant regulatory intelligence and safety reporting guidelines when preparing and
• Organize, maintain, and file safety-related documentation in electronic or physical formats

🎯 Requirements

• Bachelor's degree in Life Sciences or a related discipline, or a qualification as a registered
• Previous experience in safety reporting, pharmacovigilance, clinical research, or a related
• Familiarity with safety database systems and pharmacovigilance processes is an advantage.
• Working knowledge of medical terminology is preferred.
• Good understanding of ICH guidelines and regulatory requirements relating to pharmacovigilance and
• Familiarity with Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), SOPs, Work

🎁 Benefits

• Fully remote opportunity: Work from home in Brazil.
• International exposure: Collaborate with global clinical research and pharmacovigilance teams.
• Professional development: Build specialized knowledge in drug safety reporting, pharmacovigilance
• Career progression: Access opportunities to develop your expertise and explore different career
• Training and development: Technical and therapeutic-area training, knowledge-sharing initiatives
• Supportive management: Work with engaged managers and experienced professionals.