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.
• Responsible for project managing and authoring of safety documents including PSUR, PBRER, PADER, RMP, CSRs, and ad hoc requests in collaboration with safety physicians.

• 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.
• 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.
• Collaborates with Clinical Safety Scientist Lead and PSL to develop materials (presentation, safety analyses / evaluation, etc.) for SMT/Product-level safety meetings

• 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.

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

Doctor Of Pharmacy - Pharmd, Pharmacy