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.

BeiGene USA, Inc. seeks Associate Director, Drug Safety Systems in Cambridge, MA:

Job Duties:

1. Support and manage the proper function, maintenance, and validation of BeiGene safety systems (safety database and other supporting systems) and ensure adherence to BeiGene policies and applicable global pharmacovigilance (PV) regulations.

2. Manage changes to the systems under BeiGene change control policy, including configuration change, dictionary, and system upgrades.

3. Contribute to development, validation and implementation of aggregate reports and ad-hoc reports and maintain required validation documents.

4. Validate, implement, and maintain data transmission gateways with regulatory authorities and partners.

5. Act as a training resource to departmental staff on the use of the safety system and safety gateways.

6. Collaborate with stakeholders to achieve time-sensitive project goals and systems deliverables while also working closely with other technical leads to provide problem resolution, demonstrating commitment, dependability, and technical expertise.

7. Act as a departmental resource by researching and consulting with others within or outside of the department to resolve issues pertaining to the safety system and interface with other PV tools.

8. Support the development of SOPs, WIs and Forms for the safety system & its maintenance.

9. Participate in the selection and implementation of additional Safety System informatics systems including signal detection and surveillance tools, safety data warehouse and reporting systems.

Telecommuting is available. Approximately 10-15% travel required per year (international or domestic).

Minimum Requirements:

Employer requires a bachelor’s degree or foreign equivalent in either pharmacy or a closely related field or information technology or a closely related field and six (6) years of progressively more responsible work experience performing pharmacovigilance and drug safety within the biotech or pharmaceutical industry.

Special Skill Requirements:

1. Demonstrated ability supporting and managing the proper function, maintenance, and validation of drug development safety systems (e.g., safety databases and other supporting systems) while adhering to internal policies and global Pharmacovigilance regulations gained through six (6) years of work experience;

2. Demonstrated ability developing standard operating procedures (SOPs) for drug safety system maintenance in the biotech or pharmaceutical industries gained through six (6) years of work experience;

3. Demonstrated ability authoring and conducting Request for Solutions (RFS), coordinating product demonstrations, and gathering technical and business requirements from stakeholders to select and implement safety system informatics systems (e.g., signal detection and surveillance tools, safety data warehouse, and reporting systems) gained through six (6) years of work experience;

4. Demonstrated ability coordinating with regulatory authorities and internal stakeholders to implement and maintain data transmission gateways gained through three (3) years of work experience;

5. Demonstrated ability ensuring compliance with ICH standards including: E2B, R3, R2, and HL7 gained through three (3) years of work experience; and 6. Demonstrated ability utilizing AXWAY and BizConnect to implement and maintain data transmission gateways gained through three (3) years of work experience. All years of experience may be gained concurrently. Any suitable combination of education, training and/or experience is acceptable.

Telecommuting is available. Approximately 10-15% travel required per year (international or domestic).

Disregard the below range, the selected candidate will earn a wage of $157,700.00 – $236,500.00 per annum.

Submit resume with references to: Req.#: 24-150322 at: ATTN: Amy Nobriga, us.recruiting@beigene.com.

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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: $149,800.00 - $199,800.00 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.