Associate Director, Safety Reporting

 Posted a day ago
     
 $162K - $203K per year
  
5-10 years experience
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AI Summary

The Associate Director will manage the maintenance and validation of safety data and analytics solutions while ensuring adherence to global pharmacovigilance regulations. They will also contribute to the development of aggregate safety reports and provide technical expertise to support departmental safety systems.

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.

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.

Submit resume with references to: Req.#: L24-150319 at: ATTN: Amy Nobriga, us.recruiting@beonemed.com.

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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.

We are proud to be an equal opportunity employer. BeOne 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

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