BeOne Medicines USA, Inc. seeks Associate Director, Safety Reporting in Cambridge, MA:
Job Duties: Support and manage the proper function, maintenance, and validation of data & analytics solutions (business intelligence, automation) and adherence to BeOne Medicines policies and applicable global (PV) regulations. Manage changes to the data & analytics solutions (business intelligence, automation) under the BeOne Medicines change control policy, including configuration changes and system upgrades. Manage the development and validation of required aggregate safety reports. Contribute to ad hoc report specification, development, validation & implementation and maintain required validation documents. Manage timely flow of business intelligence information to users. Act as a training resource to departmental staff on the use of reporting solutions and Safety Systems. Work as a team member to achieve goals by communicating information and project status; collaborating on problem resolution; demonstrating leadership and providing technical expertise. Serve in a consultative role within or outside of the department to resolve issues pertaining to the safety system and interface with other PV tools. Participates in the implementation of additional Safety informatics systems including Safety Data mart, signal detection and surveillance tools, and reporting systems. Assist with internal and external audits of the Safety System and assist in the development of SOPs for the safety system & its maintenance.
Telecommuting is an option. Minimum Requirements: Master's degree (or its foreign degree equivalent) in Computer Science, Engineering (any field), or a related quantitative discipline, and 5 years of experience in the job offered or in any occupation in related field, OR Bachelor's degree (or its foreign degree equivalent) in Computer Science, Engineering (any field), or a related quantitative discipline, and 7 years of progressively responsible experience in the job offered or in any occupation in related field.
Special Skill Requirements: (1) Pharmacovigilance Systems (Argus Safety or any other Drug Safety Databases); (2) Writing Advanced SQL queries and developing reports using BI Reporting Tools; (3) Aggregate Safety Reports and management of inspection-related requests; (4) SDLC Process and regulatory requirements related to GxP System implementations. Any suitable combination of education, training and/or experience is acceptable.
Telecommuting is an option. Disregard the below range, the selected candidate will earn a wage of $162,400 -$203,000 per annum.
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Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, 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
Salary Range: $154,300.00 - $204,300.00 annually
BeOne 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 BeOne Medicines 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.
