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Industry ExperiencesFifteen years experience in biotech/pharmaceutical industry • 7 years in Clinical Development, in positions of Clinical Research Associate (3 years), Principle CRA/Clinical Trial Management (2 years), Director of Clinical Affairs (2 years)• 12 years in Drug Safety as Safety Operations Physician/Associate Director/Medical Case Reviewer and Safety Scientist, Sr./Executive Director, Drug Safety OperationsSafety Knowledge• Comprehensive knowledge of drug safety information collection process in clinical trial and post-marketing settings and adverse event reporting regulations• Extensive experience in medical review of ICSR with full understanding of the importance of high quality ICSRs as the foundation of safety signal detection and aggregated data analysis• Effective trainer in case review and product labeling document review• Innovative in improving process systems with tracking records resulting in increasing efficiency and quality in case review and processing• Well-informed in process/documentation automation technology Managerial Experience• Project management in clinical trials and process improvement • Personnel management➢ 2 years as Clinical Affairs Director managing 2-4 CRAs➢ 1 year as Associate Director in Drug Safety managing 2 drug safety physicians➢ 3 months as interim Director of Drug Safety managing a group of 14 employeesAcademic Research • 1 year as clinical research fellow in burn surgery department (Burn Center, West Pennsylvania Hospital, Pittsburgh, PA) • 4 years research fellow in pre-clinical studies (Massachusetts General Hospital, Harvard Medical School, Boston, MA)Medical Practice• 5 years in General Surgery• 9 years in Burn Surgery (6 years as Attending Surgeon and 3 years fellowship)
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Sr. Director, Pv And Drug SafetyBeigene Dec 2017 - Dec 2017Cambridge, Ma, Us -
Consultant For Beigene Pv & Drug SafetyMedvicer Inc Jan 2017 - Dec 2017MedVicer Inc is a Drug Safety/Pharmacovigilance consulting firm and provide drug safety physician and safety operation consulting services, including medical review of ICSRs and periodic safety reports, aggregated safety data analysis, safety signal detection, risk/benefit evaluation and management, and safety operation process evaluations.
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Executive Director, Drug SafetyExelixis Sep 2014 - Dec 2016Alameda, California, Us -
Sr. Director, Drug SafetyExelixis Aug 2013 - Aug 2014Alameda, California, Us
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Safety Operation Physician/Safety Scientist (Md)Genentech Drug Safety Jul 2004 - Jul 2013South San Francisco, California, UsResponsible for medical evaluation of individual adverse event reports and review of US periodic safety reports for delegated products. Safety Operations Physician Lead for Rituxan (autoimmune and oncology indications)• Medical Case Review ➢ Review incoming adverse event (AE) information (including IND Safety Reports) to determine required action based on internal policies and procedures ➢ Review AE selection and coding, assess seriousness and expectedness per reference documents, ensure medical content cohesiveness and comprehensiveness in case narratives, and make medical assessments and pharmacovigilance analysis on causality as required➢ Identify and define required clinically important follow-up information ➢ Implement safety surveillance policies and procedures, and provide oversight for the AE reporting activities➢ Ensure case review and assessment to meet corporate compliance requirements for global regulatory AE reporting.• Product Safety Surveillance➢ Monitor safety profile for delegated products and perform safety signal detection and preparation of relevant safety analysis and summaries for post-marketing regulatory activities for US periodic reports (USPR). ➢ Collaborate with the molecule Safety Scientist Leader (SSL) and Safety Scientists (SS) to assist in safety signal detection and issue work-up, including direct follow-up with AE reporting physicians on targeted-interest events, identifying labeling issues and recommending appropriate actions for product safety labeling reference document amendment, revision and update. -
Associate Director, Drug SafetyMerck Serono Dec 2002 - Jun 2004Darmstadt, Hessen, De• Medical assessment for individual AE reports: ➢ Assess seriousness and expectedness per US labeling for clinical trial, post-marketing spontaneous and solicited AEs ➢ Review AE selection, coding and case narrative ➢ Identify and define further needed follow-up information ➢ Follow-up with health care professionals, assist Medical Information Department in communication with physicians to answer product questions in safety and related medical information• Safety Surveillance➢ Prepare and review Periodic Reports including USPR and PSUR➢ Participate in risk management, including identifying and evaluating potential safety signals; providing analysis of product safety data for the identification of possible new and significant safety data relevant to the products➢ Maintain product safety labeling and develop risk management plan for delegated products• Managerial and Operational Responsibilities➢ Managed medical assessment team (2 physicians), including training, case load distribution and case review quality➢ Develop SOP, conventions, procedures and training materials for case review and medical assessment ➢ Participate in development of departmental policies, procedures and standard practices for case processing and assessment ➢ Participate in general drug safety reporting training to company non- safety employees) ➢ Acting Director for 3 months (during Director absence): Managed 14 employees in Drug Safety, developed case volume metrics, modified Call-Center process and database for solicited AE reporting and data collection to meet regulatory reporting requirement, and simplified non-serious and labeled AE process.
Bing Du Skills
Bing Du Education Details
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Jining Medical CollegeMedicine Science
Frequently Asked Questions about Bing Du
What is Bing Du's role at the current company?
Bing Du's current role is Drug Safety Physician Consultant (MD).
What is Bing Du's email address?
Bing Du's email address is bi****@****ene.com
What is Bing Du's direct phone number?
Bing Du's direct phone number is +165023*****
What schools did Bing Du attend?
Bing Du attended Jining Medical College.
What skills is Bing Du known for?
Bing Du has skills like Clinical Trials, Clinical Development, Pharmacovigilance, Oncology, Clinical Research, Drug Safety, Sop, Ind, Medicine, Process Improvement, Gcp, Project Management.
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