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Clinical Trial Drug Safety Specialist I Jobs

Clinical Pharmacy Specialist, Medication Safety
By Fraser Health Authority At Surrey, British Columbia, Canada
Participate in patient education and discharge consultations and provide recommendations in the planning and treatment assessment policies and procedures
Conduct pharmacological education or in-service sessions
One (1) year's pharmacy experience in the designated specialty area.
Competitive salary package, including comprehensive health benefits coverage.
Broad knowledge of organization policies, procedures and standards of care
Knowledge of evidence-based clinical practice
Drug Safety Specialist Jobs
By Integrated Resources, Inc ( IRI ) At River Drive Park, Ontario, Canada

MUST be HCP (pharmacist, nurse, dentist, physician) AND bilingual (French/English). Majority of interview will be in French. Responsible for all stages of adverse event reporting for clinical ...

Drug Safety Specialist - Bilingual
By Integrated Resources, Inc ( IRI ) At Toronto, Ontario, Canada
Effective written and oral communication skills in English and French.
Organizes data and narratives regarding adverse events, particularly short and long-term effects, involving clinical study or post marketing drugs and products.
Maintains adverse event files and tracking systems.
Assists with the preparation of adverse event reports for submission to regulatory agencies within the appropriate reporting timeframes.
Compiles and organizes information obtained from health professionals and consumers regarding possible adverse events.
Gathers and arranges cumulative safety data for submission to regulatory agencies.
Drug Safety Specialist Jobs
By Integrated Resources, Inc ( IRI ) At Toronto, Ontario, Canada
Effective written and oral communication skills in English and French.
Organizes data and narratives regarding adverse events, particularly short and long-term effects, involving clinical study or post marketing drugs and products.
Maintains adverse event files and tracking systems.
Assists with the preparation of adverse event reports for submission to regulatory agencies within the appropriate reporting timeframes.
Compiles and organizes information obtained from health professionals and consumers regarding possible adverse events.
Gathers and arranges cumulative safety data for submission to regulatory agencies.
Drug Safety Mailbox Admin
By Bayshore HealthCare At Mississauga, Ontario, Canada
Knowledge of local Pharmacovigilance requirements and principles.
Experience working with data entry portals and applications an asset.
Manage Centralized Pharmacovigilance (PV) Email Inbox and conduct follow ups as required.
Assist the Drug Safety and Medical Information (DSMI) team with CRM data entry as needed.
Experience in Pharma or Healthcare setting.
Knowledge of Health Canada guidelines on Reporting Adverse Reactions for Marketed Health Products.
Drug Safety Scientist Jobs
By Bayshore HealthCare At Mississauga, Ontario, Canada
Local management of Safety Information and source data including reconciliation with MAH.
Preparation and submission of Local Risk Management Plan in the Territory.
Knowledge of pharmacovigilance processes including global and local regulatory requirements.
The evaluation of the publications ensures high medical quality and compliance with health authority requirements regarding literature review and case handling.
Maintain up-to-date product and disease state knowledge to aid in literature review.
Knowledge of Pharmacovigilance guidelines and regulations.
Drug Safety Associate Jobs
By SetupmyHR At Canada
Play an integral role in the management of daily operational activities of the Global Submissions Team within Case processing.
Collaborate with the Regulatory Intelligence team, Safety Data Management to maintain accurate reporting rules in the Safety Database.
Identifying root causes for late ICSR submissions and providing appropriate corrective and preventive actions to Compliance and Business Management team.
Responsible for the timely submission of expedited ICSR reports to Ethics Committees and Investigators based on the country's requirements.
Involved in preparing safety ICSR submission packages to Health Authorities as per the requirements.
As Submissions SME, support local safety managers on a daily basis for all ICSR submission-related matters.
Analyst Ii – Clinical Drug Services
By Alberta Blue Cross At Alberta, Canada
Post-secondary education in the health services or medical field (i.e. Pharmacy Technician diploma, Medical Office Administration certificate/diploma), or directly related experience.
Knowledge of medical terminology and familiarity with drug names is required. Pathophysiology would be an asset.
Must possess excellent analytical, problem solving, and decision-making skills.
Must have a demonstrated ability to manage time effectively and work with minimum supervision in a team environment.
Excellent written and verbal communication skills, as well as organizational skills are required.
Assess and render decisions on Special Authorization requests according to the established guidelines for drug(s) requested and accepted medical condition(s).
Drug Safety Associate Jobs
By ICON plc At Burlington, Ontario, Canada
Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files.
Serve as a resource for investigational sites and ICON personnel on safety-related issues.
Assist with generation of study specific procedures and with identifying out of scope activities in conjunction with the MSS Functional Lead.
Medical/science background (nursing preferred) and/or bachelor’s degree or local equivalent.