Pharmacovigilance & Quality Assurance Manager

Job Description:

· Serve at the management level as the Pharmacovigilance (PV) and Quality Assurance (QA) Manager

· 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.

Job responsibilities:

· 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 collected from all sources within AESAN countries.

. Provide support to group companies in regulatory affairs, pharmacovigilance and quality assurance activities.

. Maintain and support Marketing Authorization Holder (MAH) responsibilities for company products in Singapore.

. Ensure complete and accurate completion of QA related documents including Product release, Change control, Deviation, Product complaint.

· Perform GMP/GDP audit of raw material, finished product manufacturing site, warehouse and distribution center.

· Report to the KPAP RX Chief Operating Officer, KCL PV and QA.

Education:

· Bachelors' Degree of Science, Pharmacy or equivalent is preferred.

Work experience:

· Minimum eight to ten years’ experience in Regulatory Affairs, Pharmacovigilance or Quality Assurance related work.

· Must have good track record of working experience with Japanese company.

Requirements:

· Demonstrated ability to manage multinational project to launch pharmaceutical products

· Conversant in GMP/GDP requirement, and medical/pharmacovigilance/regulatory terminology

· Must be fluent in Japanese (both writing and speaking JLPT N1 level) to liaise with our head office in Japan and business counterpart in business letter and contract in Japanese.

· Must be fluent in English at business level (both writing and speaking)

Interested candidates who wish to apply for the advertised position, please email us an updated copy of your resume.

We regret that only shortlisted candidates will be notified.

Email Address: [email protected]