.Over 130+ global and 1000+ local Pharmacovigilance (PV) Agreements : make a difference every day by supporting the end-to-end lifecycle management of PV Agreements. Be a part of a dynamic team who oversees, develops and negotiates PV Agreements for licensing IN, licensing OUT and co-marketing of Novartis Group products. Play a direct role in transforming the Novartis Group product portfolio and implementing the CEO's vision to Reimagine Medicine!Your responsibilities include, but are not limited to:Manage global vigilance agreements with external business partners by leading and performing the negotiations and defining the conditions of the agreement, representing Novartis policies and standards.Communicate requirements to concerned Patient Safety functions and other line units to ensure compliance with global vigilance agreements.Advise local Patient Safety team on strategy of local vigilance agreements, control and support compilation.Support and advise internal units on how to meet vigilance requirements for Clinical Trial Supply Agreements.Maintain knowledge of regulations/guidelines for pharmacovigilance and device vigilance and provide expertise to concerned external and internal stakeholders.Keep regular contact with key customers to facilitate agreement compliance and good relations; act as key contact person to identify needs and address resolution of issues.Ensure external business partners and CMO&PS management are alerted to compliance and reconciliation issues and corrective actions are developed.Perform timely review and updates to vigilance agreement and support its implementation.Commitment to Diversity & Inclusion : Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Minimum requirements:Degree in Biomedical Science or related scientific discipline. Higher degree desirable.Fluency in spoken and written English, knowledge of other languages desirable.Minimum 3 years' experience in (pharmacy) vigilance, clinical safety, or in a regulatory/compliance related area.Experience in clinical trial safety preferable.Good current knowledge of industry regulations and guidelines in the field of Pharmacovigilance and/or device vigilance.Strong interpersonal communication skills.Why consider Novartis? 769 million. That's how many lives our products touched in 2020. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives? We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data
