摘要
About the Role
Major accountabilities:
- 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.
- Mentor and train new starters -Distribution of marketing samples (where applicable)
Key performance indicators:
- Adherence to Novartis policy and guidelines -Project & stakeholder feedback -Operational risk mitigation and audit/inspection findings -Quality and timely reporting of KPI and safety reports/updates -Results of audits/inspections
Minimum Requirements:
Work Experience:
- Functional Breadth.
- Managing Crises.
- People Challenges.
- Project Management.
- Operations Management and Execution.
- Collaborating across boundaries.
Skills:
- Databases.
- Employee Training.
- Pharmacovigilance.
- Project Management.
- Reporting.
- Safety Science.
Languages :
- English.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
