仕事内容【職務内容】
The Global Patient Safety (GPS) Global Medical Review, Advisor, and Senior Advisor role is responsible for medical review of adverse events for investigational and marketed drugs in compliance with the Pharmaceutical Affairs Law, Good Vigilance Practice (GVP), Good Post-Marketing Study Practice (GPSP), Good Clinical Practice (GCP), Standard of Operating Procedures (SOP), and Safety and Efficacy Quality System-Safety (SEQSS) in Japan. This includes medical review of individual case safety reports (ICSRs) of investigational and marketed drugs; maintaining awareness of Japanese and global pharmacovigilance regulations; ensuring regulatory compliance for expedited submission of individual case reports; collaborating with internal and external business partners; as well as other duties as assigned. The Medical Reviewer provides leadership for Global Patient Safety (GPS) Safety Management, Reporting and Safety Data Sciences (SMRD) and guidance to case managers, as appropriate.
・Primary responsibilities
Medical Support of Adverse Event Reporting Process
Provide the medical and clinical expertise to support the management and evaluation of ICSRs and their assessment for reporting.
Work closely with the other Regional Medical Reviewer(s), Global Medical Reviewers, Case Management, personnel, and the GPS Medical physicians and scientists (global and Japan) to ensure appropriate communication and the medical quality of ICSRs.
Keep updated on global regulatory issues and practices related to pharmacovigilance activities in Japan.
Assist in supporting customer response activities associated with adverse events.
・GPS Medical Leadership
As a medical role of GPS for spontaneously reported and clinical trial individual case safety reporting, contribute to the global assessment of safety of this company's products and molecules in clinical trials by interacting directly or indirectly with the GPS Medical physicians and scientists and Safety Surveillance Teams (SSTs) and Japan Safety Management Teams (SMTs) involved in assessing the safety profile of products. This responsibility may require involvement in discussions related to management of marketed products and developmental product safety with the above team members.
Participate in process development, quality review, continuous inspection and audit preparedness and inspection/ audit support, and similar activities in response to a changing regulatory environment or corporate priorities.
Act as the GPS Medical Review representative for both internal and external customers, interacting as prescribed in corporate guidelines and policies.
Build strong relationships with key customers, representing and championing the role of safety in the organization.
As appropriate, provide leadership for Safety Management, Reporting and Safety Data Sciences (SMRD). This leadership might be provided through technical and/or administrative oversight of global case management activities, what includes providing technical excellence; identifying functional resources and building knowledge of pharmaceutical industry; identifying and communicating areas for scientific and process improvements and participate in change within the organization; creating an environment wherein training and mentoring is valued; and facilitating the training of other Medical Reviewers. in the responsibilities of the role, as needed.
Understand the roles and responsibilities of the European Union Qualified Person Responsible for Pharmacovigilance (QPPV) and support the QPPV role. Other job expectations
Maintain compliance with all assigned training.
Develop Global Patient Safety expertise through discussion and training programs.
Drive safety related training programs and presentations.
Support Japan GPS Medical Reviewer(s) in the Principal, Senior Principal role
Meet the R&D Titles Expectations as outlined in the R&D Titles Framework. Maintain medical expertise in areas of interest or specialty.
Understand and comply with all compliance policies, laws, regulations, and the Red Book.
Adapt to the changing global regulatory environment.
Understand the confidential nature of company information and take necessary steps to ensure its protection.
経験・資格【Minimum Qualification Requirements】
●Have which one experience
・Advanced medical related graduate degree, such as: M.D., DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with experience in related scientific field, e.g. Pharmacology, physiology, microbiology or scientifically related field.
OR
・BS degree in a health-related or scientific field with experience in pharmaceutical industry, directly related clinical trial experience or experience in areas relevant to drug discovery or development, e.g. epidemiology, toxicology, Pharmacovigilance, regulatory affairs.
OR
・ clinical experience, or pharmaceutical experience, which was clinical development experience.
And
●Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
●Effective communication skills (Japanese and English, verbal and written) to respond effectively to customer requirements and requests.
Preferred Skills
Facility in the use of computer-related tools essential (e.g. word processing, e-mail, web browsers)
Ability to work in a global environment (virtual tools)
Leadership (i.e. working autonomously, influencing without authority, ability to network ideas in corporate environment.)
Knowledge of pharmacoepidemiology
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