Leslie Cham Email & Phone Number

Toronto, Ontario, Canada

• Gained comprehensive training in pharmacovigilance activities, including preparing regulatory documents such as Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Report (PADER), and Periodic Benefit-Risk Evaluation Report (PBRER) aligned with Health Canada’s post-marketing regulations.• Conducted thorough assessments of adverse event reports and processed Individual Case Safety Reports (ICSRs) for submission to FDA’s MedWatch and Health Canada’s MedEffect program… Show more • Gained comprehensive training in pharmacovigilance activities, including preparing regulatory documents such as Development Safety Update Report (DSUR), Periodic Adverse Drug Experience Report (PADER), and Periodic Benefit-Risk Evaluation Report (PBRER) aligned with Health Canada’s post-marketing regulations.• Conducted thorough assessments of adverse event reports and processed Individual Case Safety Reports (ICSRs) for submission to FDA’s MedWatch and Health Canada’s MedEffect program. Ensured regulatory compliance and supported the company's market authorization. ICSRs completed for drugs, biologics, medical devices, human factors, medication errors, and therapeutic failures. • Contributed to continuous safety surveillance by reviewing literature, post-marketing data, and clinical trial results. Guaranteed accurate recording and reporting of safety data in accordance with Health Canada and FDA regulations.By the conclusion of the internship, I attained an in-depth foundation of the best practices in safety reporting and the regulatory standards of Health Canada, the FDA, and other international regulatory authorities that is essential to pharmacovigilance and regulatory affairs. Show less

Toronto, Ontario, Canada

• Engaged in a one-on-one mentorship program, specializing in the preparation of a NDS for Health Canada.• Gained hands-on experience in pharmaceutical regulatory affairs, focusing on the detailed preparation of NDS using modules 1 to 5 of the Common Technical Document (CTD) Backbone.• Developed an in-depth understanding of electronic CTD regulatory requirements and best practices for NDS preparation, with relevance to international regulatory authorities including Health Canada and the… Show more • Engaged in a one-on-one mentorship program, specializing in the preparation of a NDS for Health Canada.• Gained hands-on experience in pharmaceutical regulatory affairs, focusing on the detailed preparation of NDS using modules 1 to 5 of the Common Technical Document (CTD) Backbone.• Developed an in-depth understanding of electronic CTD regulatory requirements and best practices for NDS preparation, with relevance to international regulatory authorities including Health Canada and the FDA.By the end of my regulatory affairs internship, I had successfully prepared a submission-ready New Drug Submission (NDS) for Health Canada, having mastered the electronic CTD requirements and best practices specific to their standards. This experience honed my skills in regulatory compliance and detailed document preparation. Show less

Toronto, Ontario, Canada

Department: Renal Physiology Lab• Led sponsor-initiated renal disease and diabetes clinical trials by applying robust project management skills, including quality management, efficient budgeting, and resource allocation. Achieved national top site recruiter status and consistently surpassed study deliverables.• Optimized clinical trial processes through innovative collaboration, developing protocols, creating operating guides, maintenance of Trial Master Files (TMFs), and establishing… Show more Department: Renal Physiology Lab• Led sponsor-initiated renal disease and diabetes clinical trials by applying robust project management skills, including quality management, efficient budgeting, and resource allocation. Achieved national top site recruiter status and consistently surpassed study deliverables.• Optimized clinical trial processes through innovative collaboration, developing protocols, creating operating guides, maintenance of Trial Master Files (TMFs), and establishing an Electronic Document Management System. Implemented Standard Operating Procedures (SOPs) and conducted data capture training. These initiatives led to a 100% reduction in site errors and enhanced data integrity, while ensuring rigorous quality assurance throughout the process.• Co-authored peer-reviewed journal publications, advancing clinical research knowledge through meticulous data collection, collaborative research initiatives, and expert manuscript preparation.• Expertly managed the systematic collection, assessment, and timely reporting of adverse events in clinical trials. Devised and implemented robust risk mitigation strategies, significantly reducing adverse event occurrences in principal investigator-initiated trials. Show less

Toronto, Ontario, Canada

Department: Renal Physiology Lab• Facilitated team meetings and served as primary communicator for sponsors and vendors. Aligned team’s scope of project with sponsors’ expectations, fostered successful partnerships, maintained quality operations with vendors, and earned high regard from study monitors for team’s study execution.• Crafted regulatory documents for submissions to local regulatory authorities and engaged in anticipatory problem-solving to avoid future concerns related to… Show more Department: Renal Physiology Lab• Facilitated team meetings and served as primary communicator for sponsors and vendors. Aligned team’s scope of project with sponsors’ expectations, fostered successful partnerships, maintained quality operations with vendors, and earned high regard from study monitors for team’s study execution.• Crafted regulatory documents for submissions to local regulatory authorities and engaged in anticipatory problem-solving to avoid future concerns related to regulatory documents. This resulted in consistently meeting submission deadlines and maintaining regulatory excellence.• Managed and executed the complete spectrum of clinical trial processes at the site, from site selection and activation through to close-out, in accordance with Health Canada regulatory requirements. Mentored 50% of new staff in regulatory compliance and trial execution. Show less

Toronto, Ontario, Canada

Department: Renal Physiology Lab• Contributed to the development and maintenance of electronic case report forms (eCRFs), spearheaded regulatory data management initiatives, performed audits of site’s trial data, and ensured conformity of critical information. This contributed to efficient reporting processes and maintained regulatory standards for successful clinical trials.• Enhanced patient safety by providing medical information, implementing consent processes and initiating drug… Show more Department: Renal Physiology Lab• Contributed to the development and maintenance of electronic case report forms (eCRFs), spearheaded regulatory data management initiatives, performed audits of site’s trial data, and ensured conformity of critical information. This contributed to efficient reporting processes and maintained regulatory standards for successful clinical trials.• Enhanced patient safety by providing medical information, implementing consent processes and initiating drug safety protocols, resulting in high trial participant retention.• Managed project timelines, ensuring timely updates and effective communication of changes to clients and teams. Worked closely with stakeholders to renegotiate deadlines when necessary, maintaining project alignment with client expectations. Show less

Toronto, Ontario, Canada

Department: Renal Physiology Lab• Conducted physiological studies and clinical trials on diabetes and kidney health. Acquired a solid foundation in clinical trial frameworks, product development pathways, and regulatory procedures which contributed to precise research methodologies and comprehensive participant care.

Toronto, Ontario, Canada

I have had the privilege of working in both General Internal Medicine (GIM) and the Mental Health unit. I managed a diverse range of patient health conditions, including cancer, metabolic diseases, and mental health conditions. My responsibilities encompass conducting comprehensive nursing assessments, designing and implementing individualized care plans, and adopting a proactive and holistic approach to patient-centered care.I have demonstrated my ability to connect with patients… Show more I have had the privilege of working in both General Internal Medicine (GIM) and the Mental Health unit. I managed a diverse range of patient health conditions, including cancer, metabolic diseases, and mental health conditions. My responsibilities encompass conducting comprehensive nursing assessments, designing and implementing individualized care plans, and adopting a proactive and holistic approach to patient-centered care.I have demonstrated my ability to connect with patients, fostering a strong rapport and effectively de-escalating crisis situations when necessary. My cross-training in both units led to me being selected by my manager to train nursing staff in a wide range of GIM and mental health nursing skills, highlighting my proficiency in these areas. Show less

Master Of Science - Ms, Regulatory Affairs

Activities and Societies: Lux. Veritas. Virtus. Society (Honours Distinction): Honored to be one of two students selected from the Toronto.

Bachelor Of Science In Nursing (B.Sc.N), Registered Nursing/Registered Nurse

Hons. Bachelor Of Science, Kinesiology And Health Science