Serves as scientific safety leader for assigned Novartis projects / products. Once the project team is formed, responsible for the integration, analysis, and interpretation of safety information from all sources, including preclinical through lifecycle management (post approval) and externally.
1.Responsible for safety issue management from end of Phase I (POC) through Life Cycle Management.
2.Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, postmarketing data, and other sources.
3.Develops and updates, at milestones, the safety profiling and risk management plan from end of Phase I (POC) through Life Cycle Management, as relevant.
4.Leads Safety Management Team. Serves as safety representative on Global Program Teams (extended or core member)
5.Manages Drug Safety Monitoring Board activities for assigned projects / products, as required.
6.Responsible for responses to inquires from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards.
Responsible for responses to legal queries and CPO requests involving safety issues. Ensures safety information communicated to EU Qualified Person in a timely fashion.
Education : Medical degree
Language : Fluent English (oral and written)
Professional experience :