Responsibilities:
Handling and assist management of safety related information of investigational products in accordance with GCP and support development tasks.
Handling and assist management of safety related information of marketed products in accordance with GVP
Planning and implementation of measures for securing safety such as information providing/disseminating, and assist management of those tasks
Implement and assist management of other GVP/GCP activities (archiving, SOP management, Training, Outsourcing, etc.)
Managing GVP/GPSP SOPs/WIs/other documents in Japan
Managing Vender including sign GVP agreement and PVA
Managing Organized Data Collection System (ODCS)
Main Responsibilities and Accountabilities
1. Implement and assist management of collecting and evaluating safety management information such as AEs or infection cases and reporting to authorities. (Evaluating safety management information, preparing reports, submitting to authorities, and archiving records)
2. Implement and assist management of exchanging safety information with relevant global organization and business partners.
3. Implement and assist management of preparing periodic reports and submitting them to authorities.
4. Planning and implementation of measures for securing safety such as information providing/disseminating, and assist management of those tasks
5. Implement and assist management of creating and updating CTD1.11(J-RMP) in the safety part, receiving global approval and answering PMDA inquiries.
6. Implement and assist management of other GVP/GCP activities (archiving, SOP management, Training, Outsourcing, etc.)
7. From safety perspective, join JPT and support development tasks.
8. Implementing and managing procedure documents according to GVP/GPSP and confirming global SOPs/WIs/other documents (SOP management, etc.)
9. Managing Organized Data Collection System (ODCS), including the website in Japan according to GSPV standards
10. Coordinating PVA signing in Japan in cooperation with GSPV
Job Qualifications and Experience Requirements
Education
Bachelor’s degree science is preferable;
Experience
Experience of PV activities under GCP and/or GVP; 3 years or more experience of safety is preferable.
Competencies
- knowledge of GCP/GVP/GPSP, related laws and regulations in Japan
- Proficiency in written and spoken Japanese
- Good communication skills in English
- Good communication skills both internally and externally
- Problem solving / logical thinking
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
