Patient Safety Study Manager

求人詳細

Lead impactful post-authorization studies and shape the future of patient safety in a dynamic, collaborative environment.

■About the company
Our client is a leading global pharmaceutical company committed to developing innovative treatments and improving patient outcomes worldwide. They have a strong presence in Japan and foster a collaborative and supportive work environment.

■Role & Responsibilities
You will be responsible for the successful planning and execution of post-authorization regulatory commitment studies (PARCS), leveraging your expertise in project management and regulatory compliance. You'll collaborate extensively with cross-functional teams and external vendors, ensuring studies are conducted efficiently and adhere to the highest ethical and regulatory standards. This is an excellent opportunity to make a tangible difference in patient safety while advancing your career in a reputable pharmaceutical organization.

■Main tasks include
・Develop and execute project plans for PARCS, aligning with regulatory requirements and timelines.
・Lead vendor selection and contract negotiations, ensuring optimal partnerships.
・Manage project budgets effectively, monitoring expenditures and optimizing resource allocation.
・Oversee regulatory processes and interactions with relevant authorities.
・Prepare and present regular progress reports and final study deliverables to internal and external stakeholders.
・Collaborate effectively with cross-functional teams, providing guidance and support to ensure projects meet milestones and objectives.

If you are interested in this exciting opportunity, apply now.
We look forward to hearing from you.
#LI-Hybrid

こんな方を求めています

経験・スキル

■Requirements
・Bachelor's degree in Pharmacy, Medicine, Science, or a related field.
・Experience in project management within the pharmaceutical industry, ideally with a focus on regulatory compliance.
・Understanding of relevant regulatory guidelines such as GVP/GPSP and post-marketing surveillance (PMS).
・Proven ability to manage multiple projects simultaneously and meet deadlines.
・Excellent communication and interpersonal skills, with the ability to collaborate effectively with diverse teams.
・Business-level English and Japanese language proficiency.

学歴

大学卒業以上

募集要項

職種

臨床開発、CRA、CRC

給与

年収 800 〜 1,200万円

賞与

-

雇用形態

正社員

雇用期間

期間の定めなし

就業時間

09:00～18:00

休日休暇

土曜日　日曜日　祝日

保険

健康保険　厚生年金保険　雇用保険

受動喫煙防止措置

敷地内禁煙

特長

外資系企業

業種

医療機器・医療品関連

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