PV Case Processor

Case Processor

Work location

Hybrid work model (1–2 office visits per week)

• Tokyo Office: Closest station – Hanzomon
• Osaka Office: Closest station – Namba

Office location (Tokyo or Osaka) will be based on candidate preference.

Language Requirements

Native-level Japanese, and English proficiency in reading and writing (speaking is a plus)

Main Responsibilities

• Handle a full range of pharmacovigilance (PV) tasks, including case intake, ID assignment, assessment, data entry, quality control (QC), draft report creation, literature review, research-related activities, and other administrative duties.
• Collaborate efficiently with clients, offsite teams, and offshore locations to ensure smooth execution of all PV operations.
• Provide guidance and oversight to team members (including offsite and offshore) on processes and deliverables.
• Ensure all client requests are completed within the required deadlines.
• Clarify any unclear information from clients and resolve questions.
• Maintain smooth communication with clients and act as a liaison between clients, offsite, and offshore teams when needed.

Required Skills And Experience

Experience:

• At least 1 year of hands-on PV experience (case intake, assessment, data entry, QC, report drafting, query handling, literature review, etc.)

Education:

• Bachelor’s, Master’s, or Doctorate degree in health/life sciences (e.g., science, pharmacy, medicine, nursing), or
• At least 2 years of experience in healthcare, clinical research, or clinical practice.
• Knowledge of Japanese pharmaceutical regulations, including the Pharmaceutical Affairs Law, GVP/GPSP ordinances, and related operations.
• Language Skills: Native-level Japanese and strong English reading and writing skills (speaking ability is a plus).
• System Experience: Familiarity with Argus safety database.

Preferred Skills And Experience

• Strong attention to detail and ability to build positive relationships.
• Experience training team members, with clear and logical communication skills.
• Experience interacting with clients, including responding to inquiries and building trust.

Additional helpful experience includes:

• Managing deadlines and tracking progress.
• Team or people management.

Ideal Candidate Profile

• Able to work independently and collaboratively to help the team and organization achieve top results.
• Excellent communication skills and ability to build strong relationships with clients and team members in Japan and abroad.
• Possesses leadership and team management abilities.
• Logical thinker with initiative and flexibility to meet client needs and solve problems.
• Highly motivated to learn proactively and continuously.