Barbara Taylor Email & Phone Number

Canada

Burlington, Ontario, Canada

-Responsible for the Pharmacovigilance and Medical Device Vigilance department and safety team. Activities include processing adverse events and medical device incidents, reporting serious cases to Health Canada, authoring quarterly safety summary reports, writing safety data exchange agreements, implementing safety processes, training staff on all safety aspects, authoring departmental SOPs.-Lead company representative for DEL and MDEL inspections.-Responsible Quality Person overseeing the local QMS for the company which includes managing deviation and CAPA process, incoming product inspection and release activities, SOP creation and lifecycle management, product quality complaint management, executing quality agreements with internal and external partners.-Managing vendor relationships for quality and regulatory activities.-Continuously improving local Quality Management System by addressing procedural gaps, adding quality oversight to existing processes where required, providing education to employees (GMP, Good documentation practices, etc.) to improve culture of quality at the company.-Currently working with SAP, Master Control, SmartSolve, JIRA platforms.

Burlington, On

-Brought Pharmacovigilance and Medical Device Vigilance activities in-house and saved the company $100K in outsourced contracted safety activities annually.-In charge of product safety activities for drugs, medical devices and cosmetics. This included case intake, processing, follow-up and case reporting to authorities.-In charge of quality complaint case processing and evaluating case samples.-Trending of complaints and hosting Quality Management Reviews.-Implemented a Quality Management System locally.-SOP management, creation and review.-Quality release of Medical Devices.-Staff training on complaint handling procedures nationally.-Created standard responses for Medical Information requests.

Cambridge, Ontario

-Improved the company quality complaint process by rewriting the workflows, eliminating redundant steps and developing visual flow chart aids.-In charge of quarterly quality product trending and executive company complaint summaries. Delivered information through exceptional technical report writing.-Prepared data and summary tabulations for government aggregate reporting (PADER/ASR).-Submitted 15-day serious adverse event reports to Health Canada.-Performed medical coding using MedDRA, and drug coding using WHODrug dictionaries.-Conducted internal audits and issued audit reports--ensuring departments adhered to GMP regulations.

Burlington, On

-Pharmacovigilance Deputy.-National trainer on pharmacovigilance processes, system use and data entry guidelines. Trained all levels of team on new system upgrades, features and changes in government regulations.-Served on the system upgrade implementation team, executed validation test cases and successfully developed a more efficient pharmacovigilance workflow for adverse event case processing which decreased case processing time.-PV Works pharmacovigilance database key user/administrator, divisional expert of document repository, and divisional document coordinator for all SOPs and controlled documents.

Vaughan

-Task force business lead for new drug coding software (WHODrug) implementation company-wide. -Supported a drug special-access program by creating detailed SOPs as well as creating standard responses and templates to drug information requests.-Clinical Data management; data entry, CRF annotation, batch data load, identifying and resolving data discrepancies, medical coding with WHODrug and MedDRA.

Vaughan

-Monitored patient safety and treatment compliance in a drug special-access program. Verified bloodwork results and alerted patient healthcare teams if results were abnormal.-Increased patient recruitment in French-speaking provinces by 50% through outstanding bilingual customer service and exceptional relationship building with healthcare teams.

Honours Bachelor Of Health Sciences, Specialization In Health Promotion

Biology, Chemistry, Physics, Organic Chemistry, Health Sciences, Communication, Statistics, Ethics

Introduction To Adult Education

Theory and learning principles for adults. Effective training and education delivery methods for adult learners.

Medical Devices Quality Assurance & Regulatory Affairs

Key elements, processes, and best practices of strategic, risk-based QA and RA.