Bing Du Email & Phone Number

Cambridge, Ma, Us

MedVicer 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.

Alameda, California, Us

Alameda, California, Us

South San Francisco, California, Us

Responsible 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.

Darmstadt, 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.