Safety System Analyst

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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.