Senior Medical Operations Manager for PMS

About the role

BeOne is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations. We are committed to radically improving access to medicines for far more patients who need them. Our growing global team of more than 10,000 colleagues spans five continents, with administrative offices in Basel, Beijing, and Cambridge, U.S. To learn more about BeOne , please visit www.beonemedicines.com and follow us on LinkedIn and X (formerly known as Twitter). BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. Job Description: General Description: The Senior Manager, Medical Operations for Post Marketing Surveillance (PMS) is responsible for all aspects of PMS, including planning, conducting, and managing activities in compliance with Japanese regulations and GVP/GPSP guidelines. Reporting to the Director of Medical Operations Japan, this role will assist leadership in growing and building with other medical affairs functions. This position involves engagement across all functions of medical affairs, requiring enthusiasm, a positive attitude, flexibility, patience, and adaptability. The individual must demonstrate high integrity while contributing to scientific and operational excellence. Essential Functions of the Job: Post-Marketing Surveillance (PMS) Develop and revise Standard Operating Procedures (SOPs) for Post-Marketing Surveillance (PMS). Plan PMS in alignment with the Japan Risk Management Plan and medical plan. Negotiate with PMDA regarding PMS by collaborating with internal and external stakeholders. Provide appropriate training for individuals involved in PMS activities. Select appropriate vendors for database creation and execution of data collection. Optimize and simplify PMS-related activities and processes. Create periodic Safety Update Reports and re-examination dossiers accordingly. Respond to regulatory inspections, analyze, and verify improvement measures. GPSP Compliance Develop and implement a self-inspection program to ensure PMS activities comply with GPSP standards. Maintain the integrity of GPSP-related documentation, records, and systems, and propose improvements as needed. Conduct regular audits to verify compliance with GPSP requirements in all PMS-related activities. Stay updated on the latest regulations and guidelines pertaining to GPSP, sharing relevant information with the entire team. Qualification Required: Education Required: Minimum of B.S. or equivalent education Ph D or Master's Degree is preferred Supervisory Responsibilities: NA Computer Skills: Proficient in multiple computer-based tools, including software programs such as Word, Project, PowerPoint, Excel, etc. PC literacy required, with MS Office skills and handling experience with Electronic Data Capture system. Other Qualifications: Over 8 years of experience in the pharmaceutical industry. More than 5 years of experience in PMS and epidemiologic research activities. Experience as head of PMS preferred. English proficiency: TOEIC score of 720 or higher. Travel: Business travel to visit KOLs and attend major congresses. What We Offer To Our Valued Employees Market competitive compensation package including performance-based annual bonus scheme Company shares (generous welcome grant!) In-house and external learning and development opportunities Fantastic benefits program and keep improving! Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we. Join us and Make momentum in your career! BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants' personal information in accordance with applicable laws and regulations. Due to BeOne's global operation, job applicants' data will be stored overseas with adequate protection. Besides, job applicants' data will be stored for no longer than is necessary to facilitate pote