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Korean Speaking Pharmacist / Nursing

  • Full Time, onsite
  • AGENSI PEKERJAAN ICONIC MALAYSIA GW SDN.BHD.
  • Kuala Lumpur, Malaysia
RM 7,000 - RM 9,000 / month

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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