Job Description
Job Description
Serve at the management level as the Pharmacovigilance (PV) and Quality Assurance (QA) Manager.
Responsibilities
- Act as liaison between Marketing Authorization Holder of Kowa products marketed in ASEAN countries (ASEAN MAH) and Kowa PV and QA departments in Japan (KCL PV and QA) to ensure smooth day‑to‑day and long‑term operations for relevant PV and QA activities.
- Collect the most current PV and QA related regulatory information in ASEAN countries and suggest necessary actions to ASEAN MAH and KCL PV and QA.
- Constantly evaluate and maintain PV/QA systems relevant with all Kowa products marketed in ASEAN countries.
- Assist in the development and implementation of SOPs related to the PV/QA activities in ASEAN countries.
- Assist in the preparation and review of new drug and post‑approval regulatory submissions for ASEAN countries.
- Oversee the case handling process of safety information...