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 product-specific documents,including the RSI, IB, CCDS, CCSI, USPI, SmPC).• 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 Biogen's products.Communicated new and important clinical data with senior-level stakeholders across Medical Safety and provided operational support to clinical programs and special projects.Supported Commercial Team’s initiatives to strengthen HCP relationships within Biogen Safety.Provided Medical Information safety data and analysis for the preparation of Scientific publications/ journals, manuscripts, and conference materials.Performed CRO training and oversight of case processing and AESI follow-up activities, tracking internal guidelines and compliance goals for all core responsibilities (incl. triage, assessments, due diligence activities, MedDRA and WHO drug coding, clinical narratives, timely submissions, etc,).Approved Late Case Investigations (LCIs) and Corrective Action Plans (CAPAs).Mentored junior members to industry regulations, guidelines (i.e., ICH, GCP), and Biogen-specific SOPs.Co-developed and updated job-related SOPs.Validated compliance data and managed quality oversight activities that supported monthly compliance metrics for CRO and business partner activities.Managed CRO team meetings; providing job aids, real-time feedback, and quality improvements to on-the-job challenges.Coordinated the clinical data provision and analysis for aggregate reports (PSUR, PADER, Annual Reports). Worked cross-functionally with members of Global Safety to respond to special inquiries from Regulatory and Health Authorities, safety data was validated, and all commitments fulfilled.Provided support and AESI case data expertise during inspection readiness operations and audits.

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 issues, performed SAE reconciliations between Safety and Clinical databases, managed query resolution activities, contributed to design of Safety database, Safety forms, SAE reporting process, reviewed ICSRs and AESIs for signal detection activities, ensured unblinding process for SUSARS and notification of SUSARs were distributed to all reportable parties per SMP, and participated in responses for ad hoc queries from Regulatory agencies.• 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 Safety Letters, performed case follow-up activities, and ensuring timely submissions with business partners per Safety Data Exchange Agreements (SDEAs)).• 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 diligence activities, and supported aggregate report operations)• 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, expectedness, and Medra coding, follow-up activities, and submissions).• 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