製薬・医療機器・病院専門の人材紹介 エージェント会社

掲載期間:21/05/27~21/11/26 求人管理No.009615
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募集要項

国際的な安全性担当医師とネットワークを構築し、グローバルな視点から国内外の安全性情報を評価
仕事内容
・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 medical technical 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 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 Japan and externally; and Review and comment on external regulatory policy and trends affecting Global Patient Safety.
応募条件
【必須事項】
・Japanese Medical License 5year more clinical experience in Japan
・Problem solving skills, sound clinical judgment,
・ Strong leadership ability including negotiating, communication, networking and organizational skills; strong interpersonal skills and ability to influence others in order to champion safety within the organization
【歓迎経験】
【免許・資格】
【勤務開始日】
応相談
学歴
大学院博士以上
雇用形態
正社員
試用期間
6ヶ月

勤務地
【住所】 兵庫
転勤の有無
転勤なし
勤務時間
フレックス制度あり コアタイムなし
勤務開始日
応相談
休日休暇
完全週休2日制(土・日曜日)、祝日、クリスマス、年末年始・夏期 *年間休日125日、年次有給休暇、慶弔等
年収・給与
経験により応相談
諸手当
住宅手当、通勤交通費など
昇給
有り
賞与
年三回(6月、12月、3月)
採用人数
1名 
待遇・福利厚生
【待遇】
宅援助制度、借上社宅制度、グループ補償制度(医療費・歯科医療費補助制度等)カフェテリアプラン制度
【福利厚生】
選考プロセス
1)書類選考
2)一次面接
3)最終面接
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