Korean Speaking Pharmacist / Nursing
The purpose of the role is to ensure affiliate compliance with internal and external requirements concerning Pharmacovigilance (PhV) in aligned countries.
- Execute pharmacovigilance activities as nationally required (such as: adverse event management, expedited and periodic reporting, risk management and creation and maintenance of the Pharmacovigilance System Master File).
- Understand the role of the EU Qualified Person for Pharmacovigilance (EU QPPV).
- Monitor national pharmacovigilance legislation.
- Ensure appropriate interpretation and implementation of national pharmacovigilance legislation/regulation for both drugs and devices.
- Responsible for liaising with the Ministry of Health (MoH)/national regulatory authority (RA), work with legal, quality, medical and regulatory on safety issues if necessary.
- Responsible for appropriate communication between product safety locally, Global Patient Safety (GPS), and other relevant stakeholders (product complaints, medical and regulatory affairs).
- Ensure and verify that the information contained in Lilly’s Pharmacovigilance System Master File (PSMF) and associated country documents are maintained as applicable.
- Has awareness and provides input to local Risk Management Plans, local risk minimization activities and local Post Safety Authorization Studies as applicable.
- Ensure local business alliance and third-party safety agreements are in place, up to date and followed as required.
- Provide local training (initial and/or refresher) for employees and/or business alliance partners to raise the awareness of PhV, as required.
- Submit other pharmacovigilance documents to the national authority and Ethics Review Board as required (such as: periodic reports).
Job Type: Full-time
Pay: RM7,000.00 - RM9,000.00 per month
Schedule:
- Monday to Friday
Work Location: In person