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Associate Medical Director, MCR, Case Review, PV & Drug Safety

Company: BeiGene, Ltd.
Location: Ridgefield Park
Posted on: February 17, 2021

Job Description:

Associate Medical Director, MCR, Case Review, PV & Drug Safety Ridgefield Park 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. 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 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 Contribute to preparation and review answers to safety queries from regulatory authorities and IRBs as needed Contribute to preparation and review of 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. May 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-- 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 Manage continuous improvement opportunities within Medical Safety Review and ICSRM management Contribute to 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 Supervisory Responsibilities: -- no direct management responsibilities, but may be responsible for managing medical case review workload, distribution and monitoring workflow Knowledge, Skills and Education Required: ---MD, DO or MBBS or other international equivalent ---Medical case review experience and prior biopharmaceutical industry experience preferred ---2-4 years clinical experience, including training required ---1-3 years drug safety experience as medical safety review physician; 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 preferred ---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 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. 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% 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, non-disqualifying physical or mental 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. Posted 2 Days Ago Full time R5465 About Us BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. Currently employees are located in APAC, United States and Europe. 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. For more information, see www.beigene.com.

Keywords: BeiGene, Ltd., Tenafly , Associate Medical Director, MCR, Case Review, PV & Drug Safety, Executive , Ridgefield Park, New Jersey

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