Safety Systems Analyst - Pharmacovigilance

Role Overview: As a Safety Systems Analyst I in Global Patient Safety (GPS) Safety Operations, Safety Systems and Data Management, you will be the subject matter expert responsible for managing systems and databases to ensure consistent and accurate pharmacovigilance data collection, analysis, report generation, and submission tracking. Your role will involve managing routine to medium-complexity system requests, including updates to codelists, libraries, reports, dashboards, and reporting rules. You will collaborate with internal GPS functional areas and vendor resources to implement system changes and updates effectively. Key Responsibilities: - Serve as the technical subject matter expert for pharmacovigilance database systems - Manage routine to medium-complexity system requests, including updates to codelists, libraries, reports, dashboards, and reporting rules - Collaborate with internal teams and vendor resources to review and implement system changes - Ensure consistent and accurate pharmacovigilance data collection and analysis - Support report generation and submission tracking activities - Maintain a strong knowledge of pharmacovigilance system (e.g., ARGUS) and database structure - Utilize technical system skills such as Microsoft Office Tools, Power BI, SharePoint, SQL, and Databases - Apply knowledge of pharmacovigilance terminology and data entry conventions - Communicate effectively with oral and written skills, paying attention to detail - Foster teamwork through excellent interpersonal skills - Work independently under strict deadlines and changing priorities - Multitask and prioritize workload effectively on a daily basis - Demonstrate broad knowledge of relevant ICH guidelines and global regulations (e.g., FDA, EMA, PMDA) - Identify priorities and key issues in complex situations and execute issue resolution with minimal assistance Qualifications: - Robust technical understanding of pharmacovigilance database systems - Excellent analytical and problem-solving skills - Strong knowledge of pharmacovigilance system (e.g., ARGUS) with understanding of the database structure and application architecture - Strong technical system skills including Microsoft Office Tools, Power BI, SharePoint, SQL, and Databases - Knowledge of pharmacovigilance terminology and data entry conventions - Excellent oral and written communication skills with attention to detail - Excellent interpersonal skills promoting teamwork - Ability to work independently under strict deadlines and changing priorities - Ability to multitask and prioritize changing workload for self and others on a daily basis - Broad knowledge and understanding of relevant ICH guidelines and global regulations (including FDA, EMA, PMDA) Role Overview: As a Safety Systems Analyst I in Global Patient Safety (GPS) Safety Operations, Safety Systems and Data Management, you will be the subject matter expert responsible for managing systems and databases to ensure consistent and accurate pharmacovigilance data collection, analysis, report generation, and submission tracking. Your role will involve managing routine to medium-complexity system requests, including updates to codelists, libraries, reports, dashboards, and reporting rules. You will collaborate with internal GPS functional areas and vendor resources to implement system changes and updates effectively. Key Responsibilities: - Serve as the technical subject matter expert for pharmacovigilance database systems - Manage routine to medium-complexity system requests, including updates to codelists, libraries, reports, dashboards, and reporting rules - Collaborate with internal teams and vendor resources to review and implement system changes - Ensure consistent and accurate pharmacovigilance data collection and analysis - Support report generation and submission tracking activities - Maintain a strong knowledge of pharmacovigilance system (e.g., ARGUS) and database structure - Utilize technical system skills such as Microsoft Office Tools, Power BI, SharePoint, SQL, and Databases - Apply knowledge of pharmacovigilance terminology and data entry conventions - Communicate effectively with oral and written skills, paying attention to detail - Foster teamwork through excellent interpersonal skills - Work independently under strict deadlines and changing priorities - Multitask and prioritize workload effectively on a daily basis - Demonstrate broad knowledge of relevant ICH guidelines and global regulations (e.g., FDA, EMA, PMDA) - Identify priorities and key issues in complex situations and execute issue resolution with minimal assistance Qualifications: - Robust technical understanding of pharmacovigilance database systems - Excellent analytical and problem-solving skills - Strong knowledge of pharmacovigilance system (e.g., ARGUS) with understanding of the database structure and application architecture - Strong technical system skills including Microsoft Office Tools, Power BI, SharePoint, SQL