BeiGene 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.

General Description:

This role will support the GPS Safety Operations to enable process efficiency, quality and compliance. This role is responsible for supporting the oversight of ICSR data quality and compliance with global PV legislation. This role is additionally responsible for supporting analysis of processes across GPS Safety Operations, deriving actionable insights, and supporting the implementation of improvement plans.

Further, this role collaborates with GPS ICSR Management and GPS Quality Operations teams in order to ensure appropriate documentation is completed in the context of ICSR data quality, ICSR submissions compliance and ad hoc identification of potential automations or other systems enhancements to increase bandwidth and relieve cognitive load from associated teams.

Essential Functions of the Job:

Process Excellence Support

Support identification and monitoring of GPS Key Performance Metrics & Key Compliance MetricsSupport collaboration & business requirements gathering for Safety Operations Technology & Process Improvement ProjectsEnable monitoring of performance metrics in order to ensure oversight of safety operations processesSupport design and oversight of ICSR forecasting strategy and associated toolsSupport process evaluation, design, mapping & opportunity identification within Safety OperationsServe as designated point of contact for assigned processes/functions within Safety Operations & ICSR Regional Hub ModelSupport / coordinate implementation of new or updated procedures/processes, including CAPA actions, as requiredProvide consultation, as requested, on design & delivery team initiatives under Process Excellence Business Partner model

ICSR Compliance Monitoring

Responsible for ensuring complete late case reasons and immediate actions, in collaboration with Global ICSR Management LCI SMEsSupport GPS Quality Management Ops to support investigations, root cause analyses & QE/CAPA creation as requiredSupport monthly metrics generation & maintenance of PSMF KPI Annex(es)Responsible for coordination of GPS Stakeholders and Business Partners / Vendors to ensure QE/CAPAs are provided for late casesResponsible for storage & tracking of Business Partner and Vendor QE/CAPA documentationSupports Monthly Inbound Business Partner Compliance OversightResponsible for reviewing inbound case volume identification of any trendsSupport investigation of inbound case volume trendsResponsible for coordination of tracking & storage of Late ICSR Responses to BP, in collaboration with PV Alliance Management, Trials Safety Management and/or Quality Management OperationsSupport Impact Assessments for Reporting Rule updates to identify potential missed submissions

ICSR Retrospective Quality

Responsible for execution of retrospective quality check process for ICSR end-to-end workflowsResponsible for coordination with workflow SMEs on validation and alignment of the observationsResponsible for coordination of tracking & storage of Retrospective QC errorsResponsible for trending of Retrospective QC ObservationsSupport root cause analysis and action plan implementation on quality trends andResponsible for ICSR Quality Oversight aggregate analysis Retro QC & Late Cases due to data corrections

Audit & Inspection Support

Support coordination of audit / Inspection activities for Safety OpsResponsible for maintaining repository / index of inspection documents, including template listingsServe as Safety Ops SME for document QC for inspections requests

Supervisory Responsibilities:

None expected

Education Required:

Minimum of 4 years of experience in drug safety/PV or relevant in biotech/pharma industry, 2 years with an advanced degreeBachelor’s degree, or above, Life sciences, registered nurse/pharmacist/PharmD, or other health care professional or the equivalent combination of relevant education or professional experience

Computer Skills: Excel, Power Point, SharePoint, required. PowerBI and/or Business Objects preferred.

Other Qualifications:

Strong interpersonal and presentation skills, including the ability to liaise with senior leadersExcellent oral and written communicationsStrong analytic and strategic thinking skills with attention to detail. Comfortable with analytics tools & technologies.Good understanding of the need for data accuracy, completeness consistency and integrity

BeiGene 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 TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with Clarity

Salary Range: $119,200.00 - $159,200.00 annually

BeiGene is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeiGene Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.