Cassandra David Email & Phone Number

Windham, New Hampshire, US

• PV point of contact responsible for managing CRO relationship and providing oversight of daily operations.
• Assisting Clinical Development and Clinical Operations teams for start-up activities of new open label and Observational trials.Participating in the review and maintenance of PV SOPs, vendor/study plans, and.
• Generating and reviewing metrics for case quality and compliance, monitoring for trends and possible improvements, and supporting weekly and monthly reconciliations.
• Supporting aggregate report deliverables (overseeing data collection, quality reviews, and analysis process).
• Cross functional interaction with members of Safety to address safety-related concerns, inquiries, and regulatory commitments.

Providing PV Compliance, Operations, Risk Management consulting services to the biopharmaceutical industry.

• Performed extensive retrospective review of clinical cases in global safety database to ensure PV compliance fulfilled for global regulatory and health authorities.

Cambridge, MA, US

Implemented PV activities in all phases of ICSR processing and regulatory reporting for clinical and post-marketing cases.Led PML adjudication meetings for Biogen's MS franchise products as SME for Medical Evaluation Team and PV Scientists, managing safety signal detection and due-dilligence initiatives to advance the understanding of the safety profile of.

Peabody, Massachusetts, US

• Led Clinical Operations for multiple, ongoing clinical studies to address all Safety-related activities; co-authored SMPs, managed study timelines and metrics cross-functionally, proactively worked to mitigate/resolve.
• Performed in-line case review in Safety database to ensure CRO compliance objectives were met.
• Created SMQs for line listings from the Safety database in preparation of Safety Review meetings and aggregate reporting activities.
• Completed late case investigations, created training materials, and managed SOPs for vendors and incoming staff on a routine basis.

Foster City, CA, US

• Completed full case handling of Individual Case Safety Reports (ICSRs) from both investigational and post marketing products (included clinical narrative, Medra Coding, Whoevent labeling/expectedness, Investigator.
• Served as PV Lead for clinical studies to ensure all operational issues were escalated and resolved in a timely manner.
• Fulfilled Case Processing Team Leader responsibilities; monitored workflow activities to identify and escalate case processing issues/concerns to avoid late case submissions.

Boston, Massachusetts, US

• Processed clinical and post-marketed cases to worldwide Regulatory and Health Authorities (including triage assessments and case prioritization for medical assessment, data entry, narrative summaries, Medra coding, due.
• Engaged in training programs, meetings, and conferences to improve knowledge of product safety.
• Assisted in Periodic Report preparation and adverse event reconciliation reports as required.
• Developed team resources which included data collection and tracking tools, work instructions, and SOPs.

Cambridge, MA, US

• Received, tracked, triaged and completed data entry of all incoming Serious and Non-Serious adverse events for Biogen's clinical and post-post-marketed drugs (including completion of narratives, causality.
• Performed data clean up and participated in aggregate report activities.
• Created standard medical query listings to assist in the preparation of Periodic and PSUR reports.
• Contributed to the development and revision of data entry guidelines for quality improvement initiatives.

Bachelor Of Arts - Ba, Psychology

Associate'S Degree, Nursing

Graduate Certificate In Health Policy

Bachelor Of Arts (Bs), Psychology