PV Associate / Assoc. Mgr

Pharmacovigilance Associate / Associate Manager role

Location: Tokyo, Japan

Do you want to develop your pharmacovigilance experience at a world-famous, global pharmaceutical company, which is involved in biosimilars, generics, new-drug development and specialty fields?

Snapshot of duties:

• Communicate safety info on commercial & investigational drugs use
• Comply with legal & regulatory, eg, safety reports for GVP & GCP ministerial ordinances
• Develop a risk management plan in line with regulators
• Coordinating with the GVP outsourced pharma to ensure effective PV operations.
• Manage & guide GVP Contractors (CROs) performance.
• Understand global PV and overseas regulatory info, and carry out PV ops.

About the company:

• Over 100-year-old company; 4,000 products
• 40,000 staff globally, 450 in Japan; Tokyo HQ
• Sells in 60+ countries
• 200mn customers globally
• WHO's top supplier
• 400 generic drug approvals globally in the past couple of years
• 40,000 licenses maintained by company's Regulatory Affairs
• 50 manufacturing sites globally
• 25 R&D and clinical sites globally

Work experience and qualifications

Must-have experience:

1) More than 3 years of experience in safety-related work

2) PMS planning (PMSの企画立案)

3) post-marketing surveillance (市販後調査、再審査業務)

4) Experience of preparation of periodic safety reports and revision of usage precautions (安全性定期報告の作成や使用上の注意の改訂等の安全対策の業務経験)

5) Native Japanese, or minimum N1 JLPT (no less)

6) English skills (reading and writing required. Conversation is a plus; business level is highly advantageous)

Desirable experience:

• Work experience at a pharmaceutical company
• Other background (eg, CRO) is fine, but should have all 'Must-have experience' (above, points 1-6)

Persons with the following qualifications are welcome:

• Pharmacist
• Veterinarian
• Nurse
• University graduates with a science background are desirable

Salary/Annual Income & other benefits:

• Negotiable and will be at a competitive market rate
• Seasonal bonus twice a year (June and December)
• Performance bonus Once a year
• Work from home
• Flexible work time