Global Patient Safety Scientist - Orbis Clinical Contract

Pharmacovigilance; Global Patient Safety

Specialize in Life Science Industry Consulting and Regulatory Consulting to Financial Firms around FDA and EMA processes for granting marketing approval.Recent Consult Topics:- Digital Twin technology for manufacturing biologics - FDA regulatory requirements (6 week consult)- Biologic License Application Process- Overview of Pharma Services Market- Cell Therapy Patient Registries- Diagnostic Testing Landscape for Hematologic Malignances- FDA Approval for Patient Experience Data in Drug Development- Overview of the Drug Safety Space- Impacts of FDA Guidelines on Pharmaceutical Approval Process- Commercial Launch Process for Oncology Therapies in Europe- Oncological Applications for Poison Exons- P2Y12 Inhibitors- DNA/RNA, Cell & Gene Therapy Segments/Pharma Perspective

Manage safety surveillance plans and safety activities, lead Data Safety Monitoring Board coordination, and enhanced safety documentation processes for clinical trials. Develop pre-market and post-market safety surveillance plans tailored to specific products/protocols. Create and maintain safety management plans that delineate roles, responsibilities, processes, and timelines for safety activities throughout trials. Established Data Safety Monitoring Boards/Committees, including member identification, charter development, and coordination of meetings. Receive, evaluate, and manage reported safety cases, ensuring accurate data entry, preparation of serious adverse event narratives, and quality control reviews.Selected Highlights: Initiated the development of a Standard Operating Procedure (SOP) for unblinding study data, enhancing transparency and data integrity within clinical trials.Contributed to the preparation of safety-related documents for submission to regulatory authorities, facilitating compliance with reporting requirements and maintaining a robust pharmacovigilance framework.Collaborated with cross-functional teams to streamline the intake process for ongoing health studies, resulting in improved efficiency and accelerated data capture.Assisted in the creation of signal detection tools and templates, contributing to enhanced safety surveillance and early identification of potential safety concerns.Engaged in the refinement of safety management plans, ensuring that safety-related activities were executed seamlessly and in accordance with established timelines and protocols.

Contract Pharmacovigilance Scientist

Drove cross-functional leadership, process innovation, and safety enhancement. Embraced leadership opportunities, overseeing interdisciplinary teams consisting of physicians and scientists. These teams collaborated to address health authority inquiries. Centralized the review of partner documents and agreements, optimizing efficiency and ensuring comprehensive oversight. Spearheaded process transformations by advocating for a transition from organizing by indication to a functional framework, fostering greater collaboration and cross-functional integration.Selected Highlights: Strategized and executed a centralized partner document review system, optimizing accountability and fostering seamless collaboration among diverse teams, bolstering risk management and streamlined operations.Pioneered the integration of adolescents into studies, meticulously addressing lung-related medication impacts. Tailored strategies ensured patient safety, while providing unique insights crucial for medical research advancements.Led a transformative shift from indication-based divisions to functional units, amplifying cross-functional teamwork, resource efficiency, and adaptability, fundamentally enhancing overall operational efficiency.Responding to safety challenges, innovatively restructuring drug administration, significantly curbing severe neutropenia-related adverse events, ensuring patient well-being, and refining treatment efficacy.Mastered cross-cultural collaboration, harmonizing international physician teams. Navigating diverse perspectives, fostering a unified atmosphere, facilitating mutual understanding and exceptional outcomes within a multicultural setting.

Drove pharmaceutical safety through comprehensive oversight of post-marketed products and developmental drugs, expanding treatment options and ensuring effective risk management. Oversaw pharmacovigilance and global patient safety, with exposure to all aspects of patient safety management, from clinical study components to post-marketing oversight. Managed both post-marketed items and developmental drugs, contributing to the creation of comprehensive safety documentation and analysis for adverse events, particularly in the context of developmental drugs where building safety profiles from scratch required rapid adaptation and mitigation strategies.Selected Highlights: Played a pivotal role in the successful progression of the drug Kyprolis, initially a third-line treatment for multiple myeloma, by completing studies and generating comprehensive reports. This effort led to Kyprolis gaining approvals for earlier lines of therapy, including first-line use, marking a significant contribution to the company's portfolio expansion and patient treatment options.Identified and effectively managed risks associated with developmental products in the pipeline, ensuring their continued development by applying rigorous risk mitigation strategies, a critical aspect in securing the advancement of crucial pharmaceutical innovations.Expertly managed a diverse portfolio of about four developmental products concurrently, demonstrating proficiency in swiftly executing multifaceted tasks while maintaining high-quality safety documentation, showcasing an ability to efficiently navigate complex responsibilities.

Focus on Regulatory Issues

Focused Consulting, Staffing, & Drug Safety, LLC is a Management, Scientific, & Technical Consulting Business serving both Government and Non-Government entities focused on drug development.SpecialtiesPre- and Postmarket Pharmacovigilance & Risk Management Functions (Phase I to IV), Pre- and Postmarket PV/Risk Management Temporary Staffing (on-site or remote), Management, Scientific, and Technical Consulting, Drug Safety Functions. We focus on your needs. We help you attain your goals. Contact us at focused.csds@gmail.com.

Managed 41 corporate exigency contracts with about 40,000 lines of medical/surgical supplies for DLA Troop Support Medical. Performed audit visits at eleven (11) sites with materiel purchased by the government and stored by the vendor.

Responsible for working with the review division to develop a pharmacovigilance plan to monitor the safety of newly approved hematology/oncology drug products. Responsible for pre-marketing risk management functions for assigned products. Responsible for the post-marketing safety surveillance for assigned products. Develops safety signals for drug adverse event pairs, and evaluates the signal to determine if the drug is possibly associated with the development of the adverse event. Collaborates with Pharmacovigilance Physicians, Epidemiologists, Drug Use Specialists, Medication Error Specialists, and/or the REMS Specialists as necessary to develop consult, regulatory, or self-generated safety reviews. Recommends appropriate regulatory action to mitigate risk of the drugs adverse event, and briefs the decision makers on the recommended course of action. Functioned as a member or assisted groups functioning to enhance or develop new pharmacovigilance processes. Assist in mentoring junior pharmacovigilance staff.

Performed clinical reviews of submitted products for inclusion on FDA's list of specialty pharmacy (503a) approved product formulations.

My 20+ years of military service have supplied me with exceptional organizational ability, interpersonal skills, ability to work within a team, and the ability to communicate at various levels to accomplish a team’s goals. I have acted as a staff officer and specialty consultant for pharmacy issues for four Department of the Army, and one Department of Defense supply management organizations. In these roles, I was responsible for policy and regulation interpretation, reconciliation with current practices, development, and process enhancement efforts. In all these positions, I have had success in advising and assisting in defining, formulating, and ensuring successful implementation and effectiveness of new programs, policies, and initiatives meeting the needs of the organizations functions.I have managed organizations of up to 115 employees. I have managed pharmaceutical budgets ranging from $2 to $40 million dollars. I have managed personnel budgets ranging from $300,000 to $5 million. I acted as a voting member for both the Department of Defense (DOD) Pharmacoeconomic Center’s Executive and Pharmacy & Therapeutic Boards.I have managed Drug Safety Surveillance for the Department of the Army and have coordinated that same function for the Department of Defense. I have managed drug safety programs for the United States Army world-wide to include drugs and equipment in fixed medical facilities and over $55 million in deployed medical supplies which are ready for contingencies. I have worked with information technology contractors to develop programs to enhance the drug safety surveillance functions of the United States Army. The program was so successful that the United States Army, using the same staff, was able to assume the drug and medical device safety surveillance functions for all of the Department of Defense.