The Safety Data Lead I is responsible for processing adverse experience (AE) reports with high quality and compliance in the global safety system for investigational and/or marketed products, under the direction and supervision of a Global Pharmacovigilance Case Management Manager. The Safety Data Lead I performs triage, analysis and interpretation of AE data following our Company Standard Operating Procedures (SOPs) and guidelines. The SSDS supports business processes which are important to Global Pharmacovigilance Case Management operations and works closely with other staff within the organization as well as cross-functionally.
Responsibilities and Primary Activities: - Perform all core responsibilities of the Safety Data Specialist in addition to expanding the scope of Case Processing activities within or across therapeutic area(s). - Independently and consistently meet Key Performance Indicators (KPIs). - Serve as a Point of Contact, providing feedback and support to ensure resources (SOPs, guidelines) are updated appropriately to enable quality and compliance of AE reports. - Stay abreast of updates to act as resource for questions/clarifications. - Assist with the process of root cause analysis and implementation of action plans when appropriate.