David Richards, Pharmd Email & Phone Number

• Responsible for signal detection and management activities in collaboration with GDS Medical Directors.• Participate in ongoing safety data review and analysis for assigned products. Maintain Safety database and ensure expedited report distribution to the Safety Submission team.• Triage ICSRs, and evaluated ICSR data for completeness, accuracy, and regulatory report ability. Manage queries lifecycles.• Coded events, medical history, concomitant medications, and tests. Coordinated efforts from study start-up through close-out including collection and review of regulatory documents.• Led safety data reconciliation between the clinical and safety databases. Responsible for the completion and submission of ADE reports. Reviewed complaints for a potential FAR and prepare an NDA field alert report to submit to the FDA in accordance with regulations.• Responsible for project managing and authoring of safety documents including PSUR, PBRER, PADER, RMP, CSRs, and ad hoc requests in collaboration with safety physicians.• Authors high-quality aggregate safety reports to meet regulatory and internal deadlines; ensures all safety regulatory documents are processed and submitted according to regulatory requirements.• Responsible for authoring the safety section in collaboration with team members on regulatory responses, IBs/CCDS, protocol, ICF review, Data Monitoring Committees reports and requests, and other documents, and providing the necessary quality control to ensure alignment with core safety position.• Managed portfolio of products/projects related to risk management; assisted Safety Physicians in the development of risk management strategy and activities for assigned products• Assisted GDS Medical Directors to oversee risk minimization activities including tracking of activities as needed, and in the evaluation of risk minimization activity. Supported responses to regulatory inquiries related to risk management plans .

• Responsible for surveillance of all safety information for GeneDX’s products that were under development.• Supported safety surveillance of products in clinical development/early post-marketing. Performed critical analysis and medical evaluation of the emerging aggregate safety data and contribute to the establishment of the product safety profile.• Participated in preparation of communication about the benefit-risk assessment (such as Periodic Safety Update Reports, Development Safety Update Reports and Risk Management Plans)• Contributed to the development of clinical study protocols and clinical study reports. Represented Safety Surveillance in cross-functional teams. • Evaluate safety data of any source to identify potential safety signals, tracks safety signals in the global electronic signal tracking tool and performs safety analysis/evaluation. May contribute to safety action recommendations, and communication and risk minimization plans. Presents assessment to the appropriate forums, including Safety Management Team (SMT) or other cross-functional teams• Collaborates with Clinical Safety Scientist Lead and PSL to develop materials (presentation, safety analyses / evaluation, etc.) for SMT/Product-level safety meetings• Develop minimum core product safety requirements for inclusion in Clinical study protocols (CSPs) and Informed Consent Forms (ICFs)• Collaborates with Clinical Safety Scientist Product Lead and PSL to develop the Safety Management Plan for assigned product.• Review Statistical Analysis Plans (SAPs) and statistical outputs (tables, figures, and listings [TFLs]), and other clinical study documents• Collaborates with Clinical Safety Scientist Lead and PSL to author safety sections of Investigator's Brochure, aggregate reports (DSUR/PLL), Prescribing information, Company Core Data Sheet (CCDS), Risk Management Plan(s) (RMPs)

Individual Case Safety Report Processing• Performed assessments of reportability, including expectedness assessment for 3 oncology trials• Communicated with the study medical monitor to confirm the seriousness, expectedness, and causality of each event.• Confirmed events and code using MedDRA.• Identified information to be collected during follow-up site queries.• Prepared written communications to obtain follow-up information from the reporting study site.• Wrote case narratives for MedWatch/CIOMS/E2B forms and submitted for review.Client Interaction• Addressed client questions on individual cases. Completed client notifications as required for case management• Developed client-specific case processing work instructions and other documentation as needed for client-specific requirements.

Master Of Business Administration - Mba, Business Administration And Management, General

Doctor Of Pharmacy - Pharmd, Pharmacy