Technology Argus/ArisG-PV Expert

4 - 10 years

0 Lacs

Posted:2 days ago| Platform: Shine logo

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On-site

Job Type

Full Time

Job Description

Role Overview: You will be joining as a Safety System Lead or Senior Analyst in the pharmacovigilance and safety system management domain. Your primary responsibility will involve managing and optimizing Drug Safety Systems for multiple clients. As a proactive and highly organized professional, you will be expected to handle system configuration, safety report generation, and regulatory compliance efficiently. 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. Qualification Required: - 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. - Bachelors degree in Computer Science, Engineering, or a related field.,

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