Summary

Provide expertise and cross functional leadership on pharmacovigilance and/or device vigilance for all assigned Novartis Enterprise contractual arrangements including Global and Local Vigilance Agreements, and Clinical Trial Supply Agreements; and the management of transition of vigilance systems and processes (including for medical devices, and diagnostic portfolios) as part of Mer-gers & Acquisitions, divestments, in and out-licensing and other global strategic projects. Negoti-ate and maintain vigilance agreements with external business partners, managing these alliances, including oversight of compliance, and acting as key contact person for Development, PS&PV; and external customers.

About The Role

Major Accountabilities

• Expertise - Maintain knowledge of current and developing regulations/guidelines for pharmacovigilance and/or device vigilance and provide expertise and advice to all concerned Novartis line-units and external partners for Novartis Enterprise contractual arrangements and Development Integration teams (Transitions), if applicable.




• Strategy/VAP Risk Assessment (VAPRA) – take part in VAPRA activities for current deals as required to assess potential partner’s PV systems for the impact on the Novartis Enterprise.
• Negotiation and Alliance Management– Manage assigned vigilance agreements with external business partners by leading negotiations to define conditions of the agreement, guided by the EVE Director/EVE Associate Director. Ensure regular contact with key customers to facilitate agreement compliance and good relations and acting as key contact person for external and internal stakeholders to identify needs and address resolution of issues. Initiate appropriate updates to vigilance agreements in a timely manner; support Head EVE / EVE Director to ensure that vigilance agreements are implemented as required to maintain regulatory compliance and Development PS&PV; standards. Ensure accuracy and up-to-date information of agreements in t

📌 External Vigilance Engagements Lead (Hyderabad)
🏢 Novartis India
📍 Hyderabad