Pharmacovigilance Expert
About this position
The Pharmacovigilance Expert will be responsible for managing pharmacovigilance processes, ensuring compliance with global regulatory requirements, leading patient safety projects, and collaborating with various stakeholders to drive continuous improvement.
Responsibilities
• End to end management of assigned pharmacovigilance processes across Novartis Divisions
• Lead cross functional patient safety projects
• Author and maintain procedural documents for assigned processes
• Develop and maintain training material and communications for Novartis group and third party associates
• Support impact assessments on emerging regulations and ensure ongoing compliance to global regulatory requirements
• Lead process improvement initiatives including IT projects/systems
• Analyze the impact of other process and organizational changes
• Produce compliance reports and complete quality checks to monitor regulatory compliance
• Investigate root cause of delays and implement corrective and preventative actions
• Act as subject matter expert during audits and inspections
• Resolve queries from other functions and Country Organizations (COs)
• Mentor and train new starters
• Distribution of marketing samples (where applicable)
Requirements
• Functional Breadth
• Managing Crises
• People Challenges
• Project Management
• Operations Management and Execution
• Collaborating across boundaries
• Databases
• Employee Training
• Pharmacovigilance
• Project Management
• Reporting
• Safety Science
• English