グローバルCRO Project Manager, Pharmacovigilance

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仕事内容	Join this company as a Pharmacovigilance Manager and work with a team dedicated to ensuring the safety of pharmaceutical products in a dynamic and rapidly growing industry. This role is based in Japan, offering an innovative environment for research and development. You will contribute to a company that values outstanding performance, inclusion, and collaboration, while making a global impact on health and safety. Key Responsibilities As a Pharmacovigilance Manager, you will: ・Oversee a team of Safety Specialists in Japan and China from another Contract Research Organization (CRO) on behalf of a key client. ・Maintain good communications with client, CRO, and cross-functional groups within this company concerning program, ensuring seamless connection with the client’s regional and global operations. ・Collaborate with other employees in problem solving and process improvement. ・Coordinate and guide the Pharmacovigilance team, ensuring flawless execution of safety assessments and reporting. ・Develop and implement world-class drug safety strategies and processes to comply strictly with regulatory requirements. ・Manage the collection, review, and reporting of adverse event data, ensuring timely and accurate submissions. ・Successfully implement safety management plans and risk mitigation strategies. ・Promote team adherence to company policies and guidelines while encouraging an inclusive and collaborative work environment. ・Provide training and mentorship to team members, promoting professional growth and development.
経験・資格	※求人情報の応募要件全てに該当しなくても、企業様に対して内々に打診したり相談することが可能な場合もございます。一つでも当てはまる方は前向きにご検討下さい。 【必須要件】 To be considered for the Pharmacovigilance Manager position, you must have: ・A proven track record in drug safety or pharmacovigilance, with relevant experience. ・Vendor oversight experience. ・A Bachelor's degree or equivalent experience in life sciences, pharmacy, or a related field; an advanced degree or equivalent experience is highly desirable. ・Outstanding knowledge of Japanese drug safety regulations and guidelines. ・Demonstrated leadership and team management skills, with the ability to foster a collaborative and inclusive team culture. ・Excellent communication and interpersonal skills, with the ability to work effectively with diverse teams, globally. ・Demonstrates strong analytical and problem-solving abilities, paying close attention to detail. ・Proficiency in both Japanese and English, with excellent written and verbal communication skills. 【歓迎要件】 The ideal candidate will also have: ・Experience working in a global pharmaceutical or biotechnology company. ・Advanced degree or equivalent experience in a related field, such as PharmD, PhD, or equivalent. ・Proven experience in successfully managing complex drug safety projects. ・Strong understanding of data management and analytics in the context of drug safety. ・A passion for innovation and continuous improvement in drug safety practices. ・Proficiency in Chinese, with excellent written and verbal communication skills. ※更なる詳細事項は、カウンセリング（面談）時にお伝えします。
想定年収	800 万円 ～ 1000 万円
勤務地	東京都中央区、大阪府大阪市
企業データ	会社名 グローバルCRO 事業内容 全世界対象臨床試験の日本実施分の運営など
Recruiting No.	02007759000101