Safety Data Lead I

About the role

The Safety Data Lead is responsible for analyzing and interpreting adverse experience (AE) reports in compliance with regulatory requirements and internal processes. Working under the supervision of a Global Pharmacovigilance Case Management (GPVCM) Manager, the role supports both investigational and marketed products across therapeutic areas.

Key responsibilities

• Perform analysis, interpretation, and data entry of adverse event reports from a wide range of sources and therapeutic areas, demonstrating increasing proficiency in clinical knowledge, GPVCM processes and regulatory guidelines.
• Provide support or lead operational activities appropriate to level of experience and expertise.
• Collaborate with internal and external stakeholders to resolve issues of varying complexity, ensuring process standardization, adherence, and compliance with reporting requirements.
• Support simplification and optimization of case management activities to enhance overall effectiveness.

Required skills

• Case Management
• Clinical Data Management
• Clinical Knowledge
• Data Processing
• Data Validation
• Pharmacovigilance
• Regulatory Compliance
• Regulatory Requirements
• Drug Safety Surveillance