PMS Safety Monitorの求人情報なら転職エージェントJAC

求人情報

PMS Safety Monitor

  • 上場
求人番号

NJB1029983

[無料]転職サポートのお申し込み

会社名 武田薬品工業株式会社 <業種:メディカル・バイオ - 製薬>
職種

メディカル・バイオ-製造販売後調査(GPMSP)

雇用形態 正社員(期間の定めなし)
勤務地 大阪府 兵庫県
仕事内容

<目的>

This role will be charged with the safety monitoring activities for PMS studies in Japan, in collaboration with the PMS team and the relevant program teams for each therapeutic area. This individual has the required medical and scientific expertise and is able to integrate the input from various disciplines to help create, maintain, and support the execution of the PMS studies in Japan that will support the company’s business objectives.

<職務内容>

・Review and provide input into the study protocol as it is developed.

・Perform and coordinate PMS start-up activities to ensure applicable timelines and metrics are met, including all regulatory, legal and financial aspects in accordance with the local guidelines and SOPs. These include, but are not limited to site and investigator selection, collection and review of critical documents, preparation and submission of dossier for review and approval of relevant authorities.

・Provide training on the protocol and proper conduct of PMS studies to investigators and site staff.

・Perform monitoring of PMS sites, including the review of data and essential documents, and tracking of data query resolution by sites.

・Track enrolment status reports to ensure study stays on track to meet enrolment goals.

・Escalate site and PMS related issues, until identified issues are resolved or closed.

・Verify adverse event reporting according to the protocol and regulatory requirements.

・Perform study tracking and provide regular site status information to PMS Safety Monitor Manager for each assigned PMS study.

・Act as main contact for sites and coordinates all site-related communications.

・Facilitates site audits and audit findings resolution together with the sites.

求める経験、能力
年齢制限の理由

【学歴】

大卒/Degree in Health Sciences preferred

【職務経験等:必須要件】

Previous experience in monitoring PMS or clinical trials preferred

【資格:望ましい要件】ICH-GCP certification


■職種未経験者:不可

年収 600万円 - 1000万円
語学力
英語力: 
中級
ビジネスレベルの英語力をお持ちであれば尚可

ご経験・スキルを考慮したうえで、非公開求人も含めた最適な求人のご紹介もいたします。
下記ボタンよりお申し込みのうえ、キャリアコンサルタントにご相談ください。
※既に当社にご登録いただいている方はこちらをご覧ください。


[無料]転職サポートのお申し込み

新規登録


ページの先頭へ戻る