Job description
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.
Company Overview:
BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 7,700 employees across China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland and Australia, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients
General Description:
The Associate Manager, Global Safety Records and Standards is:
- Remote US
Responsible for:
- Effective execution of the activities of intake of safety information, reconciliation with internal and external groups reporting individual case safety reports (ICSR)
- Management of follow-up and due diligence activities for ICSRs
- Metrics based process management.
- Maintenance and support development of global standards, compliance and quality targets for AE collection and record management from various clinical development and post-marketing reporting sources
- Enablement of practical technical solutions and tools serving AE management and global standardization
Knowledge/Experience:
- Strong competencies with data management practices, document & records management; knowledge of medical terminology; experience with MedDRA and WHO Drug
- Understanding of applicable adverse event handling and reporting requirements (e.g., ICH E2A, E2D, GCP, FDA 21CFR312.32., NMPA Announcements, EU GVP, etc.)
- Global ICSR Case Processing, Medical Review and Submission experience preferred
Essential Functions:
Receipt and Intake:
- Ensure and oversee the receipt of ICSR from all sources including structured sources (clinical trial SAE report forms, PM AE report forms, electric formats including E2B XML, EDC, etc) and unstructured sources (emails, telephone calls, fax, mail)
- Download of AEs from regulatory portals as required
- Ensure process optimization for identification of valid vs non-valid ICSRs
- Identification of accurate regulatory reporting start date (‘day zero’) and performing duplicate searches of ICSRs
- Timely and appropriate handling of all received sources of potential adverse event and special safety situation source documents
- Notification of special safety situations to triage and/or medical review physician as appropriate
- Support daily safety database workflow to ensure ICSRs are processed according to internal timelines
Reconciliation:
- Ensure process optimization for reconciliation (i.e., receipt confirmation) of ICSR and special safety situations from various non-clinical trial sources, such as internal feeder groups (e.g., Medical Information call centers) and external sources (e.g. specialty pharmacies, CROs, external partners) as required
Due Diligence:
- Development and execution of effective due diligence query distribution to external reporters
- Support completion and monitoring of due diligence attempts
Global Standards and Compliance:
- Contribute to development global standardized rules, requirements and processes for AE collection from all reporting sources, ICSR intake and related records management
- Identify gaps/issues impacting regulatory compliance and/or quality and contribute to inspection readiness through effective collaboration with interfacing groups
- Provide inputs in business requirements definition, technical solution assessment and validation, to enable oversight of fit-for-purpose technologies and tools development to serve AE management and global standardization needs
Quality Assurance and Continuous Improvement:
- Ensure effective ongoing quality assurance through ICSR management
- Manage ongoing continuous improvement opportunities within Safety Records and Standards activities
- Conduct retrospective ICSR quality check as required
- Participate in audit and inspections as required
Training and Vendor Management:
- Develop and deliver ICSR Safety Records and Standards related process training programs as required
Performance Metrics:
- Manage the root cause analysis and actions needed on issues within the Safety Records and Standards space revealed by review of metrics
Decision Making Authority:
- In process management decisions consistent with operational policies, SOPs and WIs
- Contribute to Operational policies, SOPs and WIs
Outputs:
- Consistent process practices
- Process timelines consistent with regulatory compliance
Key Relationships:
- Safety OPS, ICSR Case Management and Aggregate Safety Reports, Clinical OPS, Medical Review Physician, Product Safety Leads, Safety Scientists, Quality Assurance, Safety Systems and Analytics
Minimum Requirements – Education and Experience:
- Minimum bachelor’s degree with a minimum of 4 years’ experience in drug safety/pharmacovigilance or relevant in biotech/pharmaceutical industry
OR
- Minimum bachelor’s degree with a minimum of 4 years’ experience in drug safety/pharmacovigilance or relevant in biotech/pharmaceutical industry
- Advanced degree preferred
Other Qualifications: NA
Supervisory Responsibilities: NA
Travel: Domestic travel as needed
Computer Skills: Safety database and other platforms required, MS Office suite
Competencies:
Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
Project Management - Communicates changes and progress; Completes projects on time and budget.
Salary Range: $106,300.00 - $141,300.00 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.
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