Safety System Analyst

Job Description

Job Title: Safety System Analyst ? Pharmacovigilance & Drug Safety Systems Location: Remote Type: Full-time Experience: 4-10 years Education: Bachelor?s Degree in Computer Science, Engineering, or related field About Us: We are seeking a highly skilled and experienced Safety System Lead or Senior Analyst to join our team. This is a leadership role within the pharmacovigilance and safety system management domain, where you will manage and optimize Drug Safety Systems for multiple clients. The ideal candidate is a proactive, highly organized professional with expertise in system configuration, safety report generation, and regulatory compliance. Key Responsibilities: Lead support, configuration, and maintenance of Drug Safety Systems for multiple clients, ensuring regulatory compliance. Mentor and lead a team of safety system analysts, providing guidance on complex system issues and optimization. Maintain strong client relationships, ensuring their requirements are met with high-quality service and timely solutions. Oversee the optimization of system performance, case processing workflows, and reporting functionalities. Manage integration of Drug Safety Systems with external systems, ensuring smooth data exchange via secure gateways and E2B import/export processes. Design, generate, and optimize Ad-hoc and Aggregate Safety Reports to ensure accuracy, compliance, and customization. Lead troubleshooting efforts and collaborate with IT teams or vendors as needed to minimize disruptions. Required Qualifications: 4-10 years of experience in pharmacovigilance, safety system administration, or related roles with hands-on Drug Safety Systems experience. Proven leadership experience in managing teams and client relationships while handling multiple clients. Extensive experience in generating and customizing Ad-hoc and Aggregate Safety Reports. Strong proficiency in Oracle SQL and PL/SQL for querying databases and generating reports. In-depth knowledge of pharmacovigilance regulations (e.g., ICH E2E, FDA, EMA) and their impact on safety system configurations. Experience integrating Drug Safety Systems with external systems and managing data import/export (E2B) processes. Bachelor?s degree in Computer Science, Engineering, or a related field.