.Summary Monitors and audits the company's drug, biologics, or medical devices surveillance program including the intake, evaluation, processing, and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance, and assessment against product labeling. Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post-marketing.About the Role The External Vigilance Alliance Manager provides expertise and advice on pharmacovigilance and/or device vigilance for all assigned Novartis Enterprise contractual arrangements including Global and Local Vigilance Agreements and Clinical Trial Supply Agreements. You will negotiate and maintain global vigilance agreements with external business partners, managing these global alliances, including oversight of compliance, and acting as the key contact person for Development, Patient Safety (PS) & Pharmacovigilance (PV) and external customers.Your key responsibilities, but not limited to; 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, for co-development agreements and full marketing agreements, and including support for Clinical Trial Supply Agreements for individual trials and for local vigilance agreements for Novartis Group Companies, as required.Take part in VAPRA activities for new deals as required to assess potential partner PV systems for the impact on Novartis Enterprise.Manage assigned global vigilance agreements with external business partners by leading negotiations/negotiating team to define conditions of the agreement with external business partners, guided by the Group Lead or senior EVAM.Ensure regular contact with key customers to facilitate agreement compliance and good relations, and acting as the key contact person for external and internal stakeholders to identify needs and address resolution of issues.With the Head External Vigilance Engagements/Group Lead communicate requirements to PS&PV functions and external line-units to ensure compliance with global vigilance agreements; with Head External Vigilance Engagements/Group Lead and Compliance Team, ensure external business partners and PS & PV management are alerted to compliance and reconciliation issues and have oversight of corrective actions and their effectiveness to improve and maintain a high level of compliance.Supervise and control local vigilance agreements, as required, to adhere to Development PS & PV standards
