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)

Essential Requirements:
•Health Care Sciences Professional (Medical background, e.g. Medical Doctor is preferred) degree or equivalent training and experience
•At least 5 years experience in pharmacovigilance
or at least 2 years safety/PV physician, clinical physician, or medical affairs experience
Desirable Requirements:
•Project management skills
•Excellent communications and negotiation (networking) skills
•Safety Science, Medical Science
•AI technic
•Fluent in both written and spoken English
•Fluent in both written and spoken local language

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

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf

Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

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