Responsible for execution and oversight of operational activities within the Distribution Configuration Management (DCM) team, including management of Distribution Anchor (DA) requests
Job Summary
Responsible for execution and oversight of operational activities within the Distribution Configuration Management (DCM) team, including management of Distribution Anchor (DA) requests.
Participate in collaborations with internal and external business partners and assist with updates to procedural documents, be involved in process improvement, metrics collection and training / mentoring of staff in DCM.
Liaises with staff in Global Medical Safety Operations (GMSO) functions (Global Case Receipt, Global Case Processing, Global Safety Reporting).
Matching Summary
Responsible for execution and oversight of operational activities within the Distribution Configuration Management (DCM) team, including management of Distribution Anchor (DA) requests.
Skills & Requirements
Must-have
Distribution Configuration Management
pharmacovigilance operations
US and EU electronic regulatory reporting
Global Safety system
Quality Control activities
Nice-to-have
Process improvement and training
Collaboration with business partners
Excellent organizational and communication skills
Key Requirements
Degree and/or relevant work experience
Developed Understanding of US and EU electronic regulatory reporting requirements for ICSRs
Accumulated expertise in pharmacovigilance operations
Knowledge of regional and global safety regulations
Good understanding of technologies, systems and databases related to E2B electronic reporting