About us

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:
This position is responsible for all aspects of patient safety within South Korea, <as the appointed Local QPPV>, as well as aspects of individual case safety reporting (ICSR), periodic report preparation, legislation monitoring, periodic literature surveillance and local standard operating procedures. The Individual will play a significant role in the establishment of the local PV system, in conjunction with Global Patient Safety strategy.

Essential Functions of the Job:
Key Responsibilities
• Responsible for establishing the national PV system.
• Acts as the point of contact for all pharmacovigilance enquires at the country level
• Appointed as the local QPPV to the National Competent Authority to fulfill its regulatory responsibilities.
• Responsible for ongoing legislation monitoring, subsequent impact assessment and recommendations relating to operational updates/modification.
• Maintains knowledge of local and international regulatory requirements, pharmacovigilance science and process best practice.
• Responsible for ICSR intake, translation (were necessary), follow-up and regulatory authority submission where applicable.
• Responsible for additional activities related to case processing including quality control and reconciliation.
• Responsible for establishing and monitoring local & regional communication channels for the exchange of safety information; triages information appropriately across Global Patient Safety and interfacing teams
• Supports preparation and/or submission of periodic reports (PSURs, DSUR, Annual reports)
• Monitor the benefit risk profile of assigned portfolio and providing evaluation to the Global Safety Management Team (SMT), or relevant safety governance committee
• Meaningfully contributes to global Qualified PV Persons Council, wherein local/regional PV updates
Docusign Envelope ID: D142BAB6-93DF-4A37-B541-22A9588E5D63
and best practices are exchanged
• Monitors and communicates in a timely manner with GPS functions about local Risk Management Plans (RMP) and risk minimization activities relevant for the territory
• Ensure effective and timely delivery of safety-related documents, such as PV part of NDA dossier, replies to Health Authority (HA) inquiries, etc
• Maintains awareness of local activities such as, but not limited to, market research, patient support programs, investigator sponsored research, non-interventional studies, compassionate use programs and named patient supply
• Establishes appropriate back up coverage is in place and adequately trained
• Ensures PV training and its documentation for all staff at national levels as appropriate
• Leads the development, maintenance and approval of country and/or regional SOPs, matrices and work instructions, in accordance with global and local regulation and company practices
• Monitors local BeOne sponsored websites and digital media
• Supports all inspection-readiness activities; supports during inspections and audits
• Documents, generates and communicates periodic and/or ad hoc data and insights pertaining to PV activities in their country/region
• Reviews new or updated local PV Agreements and/or Safety Data Exchange Agreements
• Identifies issues and bottlenecks in the implemented PV system; works to escalate and resolve issues with the aim of maintaining and improving operational excellence
• Works with business partners and vendors to ensure the maintenance of the PV system(s)

Key Relationships
• GPS Leadership team
• GPS Safety Science & Epidemiology (Product Safety Leads, Safety Scientists and Epidemiologists)
• GPS Safety Operations
• Regulatory Affairs
• Medical Affairs
• Quality Assurance
• Applicable Commercial division

Qualification Required:

Education Required:
• Bachelor’s degree in life sciences, pharmacy, nursing or equivalent
• Master’s degree a plus (e.g. - MPH, MS)

Experience
• Highly experience pharmacovigilance professional (8 years minimum)
• Highly experienced in South Korea requirements and ways of working
• Experience of working in small, mid-size and/or large organization
• Highly skilled in working cross functionally
• Highly skilled in working independently, troubleshooting and problem solving
• Experience of building a PV system preferable
• Ability to work across regions
• Well connected with external industry associations in the territory

Supervisory Responsibilities: None

Computer Skills: MS Office
Other Qualifications:
• Fluent in written and verbal communication skills (Korean and English)
• Competency with safety databases and learning management systems (ArisG, Argus, Veeva, ComplianceWire)

Travel: N/A

What We Offer To Our Valued Employees

• Market competitive compensation package including performance-based annual bonus scheme
• Company shares (generous welcome grant and performance-based annual equity plan!)
• 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 in Workday (currently located in the U.S.). Besides, job applicants’ data will be kept for one year to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne’s Job Applicant Privacy Policy (https://beonemedicines.com/privacy-policy).

If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne’s Job Applicant Privacy Policy as well as the relevant privacy terms.

If you have any concern, please DO NOT provide any resume or other personal information to us.