Safety Assistant Manager

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

Bachelors 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 worlds largest plasma collection networks CSL Plasma. Our parent company CSL headquartered in Melbourne Australia employs 32000 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 and CSL Plasma at 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 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 Experience:

Manager