Scaling Japanese ICSR Operations with 65 Bilingual Experts in 6 Months
Managing increasing adverse event volumes following a product launch can place significant pressure on pharmacovigilance operations, particularly when specialist language capabilities and strict regulatory timelines are required. A US-based top 10 global pharmaceutical company partnered with Qinecsa to rapidly expand its Japanese Individual Case Safety Report (ICSR) processing capability and maintain operational performance for a recently launched product.
The engagement required experienced bilingual professionals to support safety case intake and processing activities across Japanese and global safety systems. This case study highlights how Qinecsa successfully scaled operations while maintaining quality and regulatory compliance.
The Challenge
Following the launch of a new product, the client needed additional support to ingest and process safety cases originating from Japan. Cases were required to be entered into the client’s ICSR Intake tool and subsequently processed within the Global Safety Database.
Specialist Language and Pharmacovigilance Expertise
The project required experienced bilingual resources with both English and Japanese language proficiency. These professionals would perform critical pharmacovigilance activities including book-in, data entry, prioritization, and labeling of cases from domestic Japanese sources.
To meet demand, more than 60 qualified resources needed to be recruited and onboarded within a six-month timeframe, creating a significant operational and staffing challenge.
The Qinecsa’s Approach
Qinecsa leveraged its expertise in Case Processing Services, Pharmacovigilance Operations, and Resource Augmentation to deliver a scalable solution tailored to the client’s requirements.
Dedicated Recruitment and Onboarding Strategy
A dedicated screening, recruitment, and onboarding team was established in Japan to identify and secure suitably qualified candidates. The team focused on sourcing professionals with the language capabilities and pharmacovigilance experience necessary to support the client’s operational requirements.
Local Expertise and Program Governance
To accelerate hiring, Qinecsa worked closely with local HR teams and recruitment agencies across Japan. A senior program manager provided oversight throughout the engagement, ensuring alignment between delivery teams and client stakeholders while providing real-time status reporting to leadership.
This structured governance model enabled rapid workforce expansion while maintaining visibility, accountability, and operational control.
The Outcome
Qinecsa successfully onboarded 65 experienced bilingual resources in Japan within the required six-month timeframe. The expanded team supported the client’s safety operations, ensuring that all cases were processed within the agreed turnaround times.
Throughout the project, quality standards and regulatory compliance were maintained despite the rapid scale-up effort. As a result, the client was able to manage a significant increase in Japanese ICSR volumes while preventing the development of processing backlogs.