TAIWAN] Manager, Safety Vigilance

• Lead the planning, preparation of strategy, maintenance and execution of safety vigilance (SV) activities to realize high quality and consistency of Santen’s products (medicinal products, medical devices, supplements etc.) in Taiwan at both the development and commercial stages
• Create value for the Santen SV organization to meet globalization challenges as Santen is transforming its exciting science into valued new medicine and ensuring access to all patients around the world
• Ensure that all regional safety vigilance activities for Santen Medicines and Medical Devices is appropriate in terms of structure and performance, to comply with global standards, policies and procedures related to Safety Vigilance

• Ensures communication to Head of Safety Vigilance Group and Asia QPPV of any relevant change in relation to the product portfolio, licensing activities, clinical trial and post-marketing activities, local processes, local SV regulation, audits and inspections activities, and health authorities’ requests
• Develops and maintains strong internal cross functional and an external network to facilitate the smooth SV operations of Santen Taiwan
• Represent Taiwan SV to proactively provide SV input/support to business projects/initiatives
• Conducts safety data collection from any source and all kinds of safety reporting to concerned stakeholders is performed in compliance with internal procedures and according to current local and international legal requirements
• Maintains an appropriate single case management system, including receipt of domestic cases and distribution to global data entry, responses to queries including tracking, reporting of received cases according to local legal requirements
• Screens all local Safety Vigilance literatures
• Arranges and reviews SV related agreements in Taiwan and performs appropriate vendor management
• Provides adequate safety vigilance trainings to relevant internal/external stakeholders at country level
• Establishes and supports local inspection readiness, participate in SV audits and SV inspections as required.
• Coordinates and monitors risk minimization measures as necessary for all products in Taiwan
• Monitors local SV activities and regularly reports status to global headquarters
• Maintains awareness of local Safety Vigilance regulations and updates local Vigilance activities and processes as necessary to maintain compliance with local regulations
• Plans local SV budget, provides necessary inputs in forecasting and maintains adequate handling of SV budget
• Provides support to SV related activities/projects according to the direction made by head of SVAO at any given time

• Excellent knowledge of regulations relating to Pharmacovigilance
• Relevant experience on Pharmacovigilance
• Knowledge of products development process, eye diseases, and ophthalmic products
• Familiarity with and ability to work as a stand-alone Pharmacovigilance unit within a global Safety Vigilance Structure
• Well-organized and detail oriented, with strong verbal and written communication skills in English
• Able to effectively participate in multi-disciplinary teams; strong hands-on leadership and management skills
• Solid decision making skills, inter-dependent partnering skills, team-orientation and demonstrated ability to influence outcomes
• Solid computer skills, using MS Office / Word

Santen