[KOREA] SV Associate (1-Year-Contract, Renewable)
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Job Location:
Seoul - South Korea
Monthly Salary:
Not Disclosed
Posted on:
3 days ago
Vacancies:
1 Vacancy
Job Summary
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
Qualifications :
Bachelors 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
Additional Information :
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
Remote Work :
No
Employment Type :
Contract
Key Skills
- IVR
- SOAP
- Avaya
- Solaris
- Cost Accounting Standards
- Database Design
- Hibernate
- ITIL
- Weblogic
- Express.js
- Contracts
- ASP
About Company
As a specialized company dedicated to ophthalmology, Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices. Santen is the market leader for prescription ophthalmic pharmaceuticals in Japan and its products now ... View more
