External Vigilance Engagements Lead
Core
Lead external vigilance engagements and manage contractual arrangements for pharmacovigilance and device vigilance across Novartis Enterprise, including M&A transitions and partner compliance.
Role type
Senior IC pharmacovigilance and device vigilance lead
Builds
Global and Local Vigilance Agreements, Clinical Trial Supply Agreements, and transitioned vigilance systems for medical devices and diagnostics
Domain
Life Sciences / Pharmacovigilance / Regulatory Compliance
Deliverable
client delivery
Required skills
Pharmacovigilance regulations, Device vigilance, VAPRA risk assessment, Vigilance agreement negotiation, Transition project leadership, Regulatory compliance oversight, Safety database management, Clinical safety reporting
Preferred skills
Clinical trial safety experience, Partner management, M&A transition projects
Technologies
Clinical safety databases
Responsibilities
Maintain expertise in PV/device vigilance regulations and advise internal/external partners; Lead negotiations and manage assigned vigilance agreements with external business partners; Lead high-priority transition projects in PS&PV; Ensure compliance with vigilance agreements and transition plans; Support internal and external audits and regulatory inspections