PMS Senior Manager, Japan

Tokyo - Japan

Monthly Salary: Not Disclosed

Posted on: 12 hours ago

Vacancies: 1 Vacancy

Job Summary

Position Purpose:

Clarifying safety and efficacy of drugs through planning management and implementation of post-marketing surveillances and studies in accordance with GPSP/GCP.
Promoting appropriate use of drugs through the collection of safety management information for marketed products and execution of safety measures if required.
Summarizing outcomes of PMS and distributing useful information to customers.
Implementing and managing other PMS activities (Archiving SOP management Training Outsourcing etc.).
Assist supervising PMS team lead at a high level and extensively.

Reporting Relationships:

Reports to: PMS team lead JSPV
Positions reporting into this role: (Not specified)

Main Responsibilities and Accountabilities:

Planning management and implementation of post-marketing surveillances and studies. Preparing Japanese periodical safety reports (J-PSUR) and submission. Preparing re-examination application dossier submission and inspection. Preparing re-evaluation application dossier submission and inspection. Implementation of PMS operations based on entrustment contract.

Position Qualifications and Experience Requirements: Provide hiring requirements for the specified position including educational experiential and competency requirements necessary for the position.

Education

Bachelors degree of science or equivalent.

Pharmacist is preferable.

Experience

Experience of PMS activities under GPSP and/or GCP and/or GVP; 3 years or more experience of PMS is preferable.

Competencies

Broad knowledge of GPSP/GCP/GVP related laws and regulations in Japan.

Proficiency in written and spoken Japanese.

Good communication skills in English.

Good communication and management 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:

Senior Manager

Position Purpose: Clarifying safety and efficacy of drugs through planning management and implementation of post-marketing surveillances and studies in accordance with GPSP/GCP.Promoting appropriate use of drugs through the collection of safety management information for marketed products and execut...