PRINCIPAL ACCOUNTABILITIES

Ensures communication to Head of Asia Safety Vigilance Operation 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.

1. Develops and maintains internal cross functional and an external network to facilitate the smooth SV operations of Santen Korea.

2. 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.

3. Maintains an appropriate single case management system, including: receipt of domestic cases and data entry to global single data base, responses to queries including tracking, reporting of received cases according to local legal requirements.

4. Screens all local Safety Vigilance literatures

5. Arranges and reviews SV related agreements in Korea.

6. Conducts post marketing surveillance activities including relevant vendor management and investigator management.

7. Provides adequate safety vigilance trainings to relevant internal/external stakeholders at country level.

8. Supports local inspection readiness, participate in SV audits and SV inspections as required.

9. Coordinates and monitors risk minimization measures as necessary for all products in Korea.

10. Monitors local SV activities and regularly reports status to global headquarters.

11. Maintains awareness of local Safety Vigilance regulations and updates local Vigilance activities and processes as necessary to maintain compliance with local regulations

ESSENTIAL QUALIFICATION, SKILLS AND EXPERIENCE

List specific educational credentials (if any) including certification, degree, and licensure. Specify the number of years and type of previous experience necessary to meet minimum requirements. List the minimum skills, training, experience, and level of knowledge and abilities necessary to perform the responsibilities of this position.

l Excellent knowledge of local and global regulation relating to Pharmacovigilance

l Well-organized and detail oriented, with strong verbal and written communication skills in English

l Ability to effectively participate in cross functional teams

l Solid decision making skills, inter-dependent partnering skills, team-orientation and demonstrated ability to influence outcomes.

l Solid computer skills, using MS Office / Word.

l Knowledge of products development process, eye diseases, and ophthalmic products (Nice to have)