Leaded in the provision of pharmacy services including dispensation of medication and advising patients on usage of prescription and non-prescription drugs
Conferred with physicians regarding accuracy and clarifications on prescriptions
Monitored patient profiles for interactions, medication compliance and inappropriate therapy

Reviewed product and labeling changes to assess regulatory impact
Filed various submissions and updates with regulatory agency and provide general regulatory guidance as needed
Ongoing maintenance of submissions of regulatory filings and correspondence for specific drug programs

Responded to customer inquiries and problems by providing information or directing requests to others who can supply the necessary information or service
Built and maintained business relationship with clients by providing prompt and accurate service so as to promote customer loyalty

Analyzed territory and historical sales performance to identify sales opportunities
Ensured standards for quality, customer service and health and safety are met
Organized special promotions, displays and events

Performed audits of clinical trials, Protocols, ICFs for compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), pertinent regulations and guidelines (FDA, Health Canada, EMEA) Audited pre-study documentation, in-process activities, end-of-study documentation and clinical study reports and documented findings and recommendations in audit reports
Kept Management up to date with findings and follow up on corrective actions

Reviewed clinical source data, in-process clinic procedures and study related documents to ensure completeness, accuracy and consistency of data
Worked under the direction of the Supervisor, Quality Control and Manager, Quality Assurance to perform Quality Control functions for assigned studies
Performed QC Review of in-process clinic procedures to ensure compliance to study protocol, ICH E6 GCP, and Company's Standard Operating Procedures (SOPs)
Performed QC Review of source documents and subject files to ensure compliance to study protocol, ICH E6 GCP, and Company SOPs
Completed QC review of the assigned study documents and / or in-process clinic procedures within defined timelines
Documented findings from QC review and issues the summary of findings to Clinical Research Coordinator (CRC) / designee for corrective actions
Followed-up on the responses to the findings within the established timelines to ensure that all observations are addressed
Reported any critical or major issues to the Supervisor, Quality Control, Manager, Early Stage (Quality Assurance), Manager, Early Stage (Clinic Operations) and CRC in charge immediately
Assisted with the maintenance of the Company's SOPs
Participated in meetings and provides quality update to the team
Assisted in completing CTA applications and communicated with TPD as required