Summary In close collaboration with the Global Program Safety Lead GPSL provides robust safety evaluation expertise and medical innovation in order to improve patients lives and impact on overall Novartis results Ensures optimal patient safety for assigned compounds by identifying new safety signals early using internal and external spontaneous reporting databases Major accountabilities Lead the safety signal detection and triage activities for a challenging product portfolio Identify current safety signals early based on review and comprehensive medical evaluation of technical hits in postmarketing spontaneous reporting databases analyzing single case reports as well as aggregate data available Provide expert evaluation of results of postmarketing signal detection activities at cross-functional team meetings Product Safety Team SMT SMB Joint Safety Committees as appropriate Collaborate productively with the safety leads for the respective products and as a core member of the cross-functional SMT provide expert input for postmarketing signal detection activities using internal and external spontaneous reporting databases Provide expert input to MSRB presentations to safety team and Global Head of Safety Signal Detection Perform database searches in external Health Authority databases FAERS Vigibase analyzing and reporting the results Perform QC checks of Health Authority database searches done by colleagues Provide relevant inputs for enhancements of current systems and processes Provide safety input as it relates to postmarketing signal detection activities to safety documents as well as ad hoc Health Authority queries Act as Subject Matter Expert SME for postmarketing Safety Signal Detection including participation in initiatives and provide guidance on methodology used for automated signal detection to safety leads and cross-functional SMT SMB Manage Eudravigilance database requests i e monitoring Eudravigilance for assigned products Lead the training and mentoring o

📌 Safety Signal Lead (Hyderabad)
🏢 Novartis
📍 Hyderabad