Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world. 
 

• Manage end-to-end safety case processing (ICSR): Collect, process, and ensure timely reporting of safety information in compliance with PV regulations

• Ensure compliance with local and global pharmacovigilance requirements: Maintain accuracy, completeness, and timeliness of all safety data and documentation

• Support Risk Management Plan (RMP) and additional risk minimization activities (ARMM): Localize, implement, and track effectiveness of risk minimization measures

• Handle safety activities for clinical trials and post-marketing studies (PMS): Process safety data and support reporting aligned with study and regulatory requirements

• Maintain safety systems, logs, and documentation: Manage safety database entries, tracking logs, and ensure audit-ready documentation

• Collaborate with internal stakeholders and external vendors (e.g., CROs, call centers): Ensure effective safety data exchange, reconciliation, and issue resolution

• Support inspections, audits, and continuous compliance activities: Participate in audit readiness, SOP updates, and CAPA implementation

• Bachelor’s degree in Pharmacy, Life Sciences, or related field

• Basic understanding of Pharmacovigilance / Drug Safety processes

• Experience or exposure to ICSR processing and safety database systems

• Strong attention to detail and documentation accuracy

• Ability to manage multiple tasks and meet timelines

• Good communication skills and ability to work cross-functionally

• Proficiency in Korean and working-level English

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer.  We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.

*Please note that team assignments may be subject to future changes