[Hiring] Associate Director, Medical Safety Review Physician @BeiGene

Role Description

This position provides the medical and clinical expertise needed to perform medical review of Individual Case Safety Report (ICSR) from any source including clinical trials, literature, post-marketing studies and postmarketing spontaneous adverse event reports in order to determine the event seriousness, expectedness, company causality, evaluate medical contents and case completeness, and identify potential safety signals at single case level.

Key Relationships

• Product Safety Lead Physician
• Safety Scientists
• Safety Operations including Safety Study Lead
• ICSR Management
• Safety Systems
• ASR Management
• Clinical Development
• Clinical Operations

Essential Functions

• Serve as safety medical expert to evaluate ICSRs for all company products either marketed or in clinical development.
• Perform regular medical case review for all ICSRs reported from any source including clinical trials, literature, post-marketing studies and post-marketing spontaneous adverse event reports to ensure complete and timely review aligning with internal and external reporting timelines.
• Review all AEs and SAEs and determine whether the events are accurately reported and captured as what occurred in patient clinically and confirm that events are correctly coded with MedDRA and confirm seriousness criteria.
• Assess AE and SAE expectedness for each event per Reference Safety Information (RSI) and ensure correct, consistent interpretation and application to ICSRs.
• Review case narrative and medical contents for completeness, identify missing medical information or key data that impact medical understanding and evaluation of the case, and issue medical safety queries.
• Provide company causality assessment of reported adverse events (AE) and serious adverse events (SAE) utilizing clinical and global introspection methodologies aligned with global regulations.
• Review and approve Analysis of Similar Events, provide company comments and assessment with medical analysis for SUSAR/IND Safety Reports.
• Provide overall case assessment and pharmacovigilance comment on ICSRs as needed.
• Identify important/critical cases with potential safety signals at single case level (i.e. first line signal detection), escalating cases to Product Safety Lead Physician and Safety Scientist as necessary.
• Issue urgent medical queries on urgent follow-ups, coordinating with Product Safety Lead Physician, Safety Scientist and Medical Monitors as required.
• Determine event term MedDRA coding for SAE reconciliation.
• Contribute to the preparation and review answers to safety queries from regulatory authorities and IRBs as needed.
• Contribute to the preparation and review of any aggregate safety analysis in regulatory submissions as needed.
• Conduct training for new medical review team members.
• Act as Medical Review functional representative and provide support to cross functional projects.

Performance Metrics

• Contributing to metrics addressing internal timeline and work in progress performance (i.e. volume, quality, compliance and productivity metrics).

Quality Assurance

• Ensure effective ongoing quality assurance through ICSR review, feedback to ICSR team, issue escalation and continuous process improvement.
• Contribute to the root cause analysis of issues revealed by review of metrics.
• Support corrective and preventive actions stemming from compliance metrics review and other sources.

Compliance, Standards and Training

• Contribute to identification of standards, processes, controlled documents (including SOPs, Work Instructions, etc.) aligning with established and developing regulatory requirements for ICSR medical assessment and management.
• Contribute to the development of compliance targets and their ongoing determination.
• Contribute to and deliver training programs for Medical Safety Review Physician and ICSR personnel as required.
• Participate in and support internal and external audits and inspections including those by regulatory agency and business partners.

Continuous Improvement

• Manage continuous improvement opportunities within Medical Safety Review and ICSRM management.

Vendor Oversight

• Contribute to training, oversight monitoring, performance metrics review of ICSR vendor activities where applicable.

Minimum Requirements – Education and Experience

• MD, DO or MBBS or other international equivalent.
• Medical case review experience and prior biopharmaceutical industry experience preferred.
• Minimum of 2-4 years Clinical experience, included training required.
• Minimum of 8-10 years pharmacovigilance experience preferred, including 2-3 years as a Medical Safety Review Physician is preferred; other MD experience in the pharmaceutical industry may be considered.

Other Experience

• Excellent communication skills (verbal and writing); Clear and confident presentation skills.

Supervisory Responsibilities

• No direct management responsibilities, managing medical case review workload, distribution and monitoring workflow.

Travel

• Less than 5%.

Computer Skills

• Working knowledge of Microsoft Office Suite (e.g. Excel, PowerPoint, Visio, etc.), familiarity with MedDRA and safety database ARGUS.

Global Competencies

• 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

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.