8 July, 2022
Novartis Hiring Vigilance Quality Excellence Manager (Pharmacovigilance)
Your responsibilities include, but are not limited to:
• End to end management of assigned pharmacovigilance processes across Novartis Divisions. Responsible for ensuring compliance to global regulatory requirements with maximum efficiency -Lead assigned cross functional patient safety projects
• Author and maintain procedural documents for assigned processes and drive continuous improvement by alignment of relevant stakeholders globally and locally
• 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 assigned process improvement initiatives including IT projects/systems (leading enhancements and managing releases). Analyze the impact of other process and organizational changes
• Work in collaboration with other functions to produce compliance reports and complete quality checks to monitor regulatory compliance as well as compliance to internal requirements. In the case of any delays, investigate the root cause and develop and implement corrective and preventative actions. Measure effectiveness of actions taken
• Act as a subject matter expert during audits and inspections (e.g. FDA and EMA), lead the preparation of responses to findings and the development and implementation of corrective and preventative actions.
• Resolve queries from other functions and Country Organizations (COs) related to assigned processes and act as a consultant on regulatory requirements.
• Work jointly with other functions (like Compliance & Quality and Process Compliance & Risk Mitigation) to perform metrics trend analyses, generate knowledge and mitigate any identified risks. Mentor and train new starters.
• Operations Management and Execution
• Project Management
• Collaborating across boundaries
• Functional Breadth
• People Challenges
• Managing Crises