- Therapeutic Area Safety Physician
Provide medical leadership and input into all aspects of safety of assigned products/ area including surveillance programs and risk management plans
Ensure proactive safety surveillance:
lead risk management activities for assigned products in Japan lead and guide the surveillance activities of scientists on the team including signal detection/ evaluation activities; provide support, training and continued improvement as appropriate manage safety signals, decisions and actions to be taken, including communication to appropriate “customers” (Medical, Product team, Management, Central GPS, Regulators) and liaise with Medical science and Surveillance scientists, as appropriate, to fulfill safety obligations;
Supervise and review reports on safety issues and their implications for the Core Safety Information and Japan package insert, represent Japan safety position to local and global governance committees as appropriate.
Build collaborative working relationships with central GPS Physicians and medical/product teams both locally and globally to ensure full cooperation and high quality medical evaluation of safety data.
Represent the Japan safety on appropriate committees/product brand teams. Provide medical support for safety activities and reports within the department, as appropriate. Provide safety expertise to external customers (regulatory, medical, others). Provide medical input to review of Adverse Event cases both development and marketed compounds. Be accountable for evaluation of AE and company opinion.
Demonstrate knowledge in risk management and risk minimization, which includes understanding of relevant aspects of the regulatory, industry and scientific environments, especially in Japan.
Understand the roles and responsibility of the safety control manager and ensure support is provided to fulfill their legal responsibilities.
Medical Support of Adverse Event and Product Complaint Reporting Process：
His/her responsibility includes providing the medical expertise to support the management and evaluation of ICRs and product complaints and its assessment for reporting. This encompasses: 1) Providing medicaltechnical expertise in evaluation of individual adverse events; 2) Supporting the case management staff in ensuring appropriate follow-up; 3) Reviewing assessments of expectedness based on global reporting requirements and individual countries requirements; and Being accountable for the medical content of cases.
To meet successfully these requirements, the Japan safety physicians will work closely with the other Regional medical reviewer and Therapeutic Area Physicians/CRSs (global and Japan) to ensure appropriate clinical picture of ICRs is captured with focus on medical quality. The Japan safety physicians are also accountable for sign off on the medical content of ICRs that require medical review.
Keep current on global regulatory issues and practices related to Japan safety.
Training, Coaching, Mentoring
Provide training, coaching and mentorship to safety surveillance scientists and case managers with respect to medical aspects of surveillance.
Provide Global Patient Safety training for medical Clinical Research Physician and other audiences (e.g. Regulatory, Medical) as appropriate.
Japan Safety Leadership
Provide input to Japan Safety Leadership Team as required; actively contribute to the management of safety in Japan at strategic level.
Provide ad-hoc involvement in operations, only if required or necessary; and deputizing for Senior Medical Advisor.
Representative with Lilly Japan Presence and External Influence
Build strong relationships with key customers, representing and championing the role of safety in the organization: Brand Team (Business unit), Regulatory, Clinical Research Physicians (medical science) and External Opinion Leaders in safety area.
Represent Product Safety within Lilly Japan and externally; and Review and comment on external regulatory policy and trends affecting Global Patient Safety.
- 【年収】1100万円 ～