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
• 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.
• Act as a subject matter expert during audits and inspections (e.g. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)), lead the preparation of responses to findings and the development and the implementation of corrective and preventative actions.
• Measure effectiveness of actions taken

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

Minimum Requirements:

For this role we are searching for applicants with experience of case processing from Pharmacovigilance (PV) perspective at a local level.

They will also need to:

• Be detail orientated
• Have a systematic approach
• Have experience of GxP documentation practices

Languages :

Fluency in both Spanish and English are essential for this position

Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: http://www.novartis.com/about/strategy/people-and-culture

You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. http://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: http://talentnetwork.novartis.com/network