Responsible for completing day to day operational activities in relation to the set up and maintenance of Distribution Anchors (DAs) in the Global Safety System
Participate in collaborations with internal and external business partners to support the maintenance of the DAs to meet Regulatory reporting requirements
Help to write and update procedural documents, be involved in continuous process improvement, metrics collection and training / mentoring of other staff in DCM
Manage daily workload and ensures Distribution rule related tasks are completed timely as allocated to ensure completion of daily activities
Document local country regulatory requirements and interprets requirements into Distribution Anchors technical requirements
Act as Subject Matter Expert (SME) when requested in activities including Regulatory Reporting intelligence, Quality monitoring activities, Process/system improvement
Develop / update Standard Operating Procedures (SOPs) and other controlled documents relevant for coordination of tasks, business continuity and audit/inspection readiness
Investigate, document and track compliance related data and identify any trends

Degree and/or relevant work experience, advanced degree is preferred
Developed Understanding of US and EU electronic regulatory reporting requirements for ICSRs
Accumulated expertise in pharmacovigilance operations related activities including single case processing, database queries, expedited reporting
Knowledge of regional and global safety regulations
Good understanding of technologies, systems and databases related to E2B electronic reporting
Excellent organizational and communication skills including presentation abilities
Ability to produce high quality work under time critical and high-pressure situations
Project Management Skills desirable

Distribution Configuration Management Analyst

Key skills