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.
General 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 post marketing 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.
This position also provides the Medical Review role for assigned BeiGene products to support the Risk Management Plan updates, signal detection and management, and performs mentoring to new hires, conducts cross-function training/presentations within the GPS and Clinical Development as Medical Review Team representative; additionally, acts as Subject Matter of Expert for internal and external audits and inspections as required.
Essential Functions of the job:
-
Serves 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
-
Assessment of reported adverse events (AE) and serious adverse events (SAE) providing company causality assessment utilizing clinical and global introspection methodologies aligned with global regulations
-
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 safety medical queries
-
Review and approve Analysis of Similar Events and 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 Product Safety Lead Physician/Safety Scientist and Medical Monitors, and upper management as necessary
-
Issue urgent medical queries on urgent follow-ups, coordinating with Product Safety Lead Physician and Medical Monitors as required
-
Communicate with investigators and other AE reporters for urgent medical queries and follow-ups
-
Responsible for determining event term MedDRA coding for SAE reconciliation
-
Provide medical input and review RSI in Investigator Brochure
-
Provides the medical input and review needed for the creation aggregate reports (PBRER, DSUR, PADER) as needed to support compounds in clinical development or post approval
-
Prepare and review answers to safety queries from regulatory authorities and IRBs as needed
-
Prepare and review any aggregate safety analysis in regulatory submissions as needed
-
Conduct training to new team members in medical review and help in managing Medical Case Review team
-
Act as Medical Safety Review functional representative on cross functional projects
Performance Metrics
-
Contributing to metrics addressing internal timeline & 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
-
Perform monthly AE line-listing review to identify issues and inconsistence of event term capture and coding, and seriousness, expectedness and causality assessments
-
Assist in monthly quality evaluation of medical case review through ICSR review, feedback to Medical Review team, issue escalation and continuous process improvement
-
Perform the root cause analysis of issues revealed by review of metrics
-
Initiate 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.
-
Develop and deliver training programs for Medical Safety Review Physician and ICSR personnel as required
-
Act as Subject Matter Expert and Medical Review Team representative for internal and external audits and inspections including those by regulatory agency and business partners
Continuous Improvement
-
Lead identification and management of continuous improvement opportunities within Medical Safety Review and ICSR management
Vendor Oversight
-
Perform training, oversight monitoring, performance metrics review of ICSR vendor activities where applicable
Key Relationships:
-
Product Safety Lead Physician, Safety Scientists, Safety Study Lead, ICSR and ASR Management, Clinical Development, Clinical Operations, Safety OPS, Safety Systems
Required Education:
-
MD, DO or MBBS or other international equivalent
Required Qualifications:
-
Medical case review experience and prior biopharmaceutical industry experience required
-
2 plus years of clinical experience, including training required
-
4 plus years drug safety experience as medical safety review physician required; other pharmaceutical industry MD experiences may be considered
Competencies and Knowledge:
-
Ability to comply with Global regulatory requirements (i.e. ICH, GVP, FDA 21CFR312, GCP, NMPA Announcement (No. 66, 2018), PAL of PRC (Dec 2019)) for capture and submissions of pharmacovigilance individual case safety reports and aggregate safety reports to FDA, CDE/NMPA, EMA, MHRA, and other global regulatory authorities/national competent authorities
-
Clinical knowledge of therapeutic area patient populations and drug class is required
-
Ability to work in technical safety systems including Argus with electronic workflow and medical coding frameworks, MedDRA, WHO Drug, ICD-10
-
Thorough appreciation of the utilization of aggregate safety data
Supervisory Responsibilities:
-
No direct management responsibilities, but may be responsible for managing medical case review workload, distribution and monitoring workflow
Computer Skills:
-
Working knowledge of Microsoft Office Suite (e.g. Excel, PowerPoint, Visio, etc.), familiarity with safety database ARGUS and with MedDRA
Other Qualifications:
-
Excellent communication skills (verbal and writing); Clear and confident presentation skills; ability to network and partner within global organizations; results oriented and strong attention to detail
Travel: less than 5%
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: $231,200.00 - $291,200.00 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.
Please Note :
apexdining.ca is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, apexdining.ca provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.