Manager,Pv & Drug Safety
By SUN PHARMA At Brampton, Ontario, Canada
Manage PV/MI (medical information) service provider to ensure compliance to contractual agreement and regulations
Three to Five years related experience.
Previous experience interacting with Health Canada or other regulatory agencies.
Excellent written and verbal communication skills.
Strong analytical and research skills.
Strong interpersonal skills with the ability to build strong working relationships with key stakeholders.
2930 Drug Safety Testing Immunologist
By Hess Associates Executive Search At Montreal, Quebec, Canada
Hands-on experience running and supervising immunoassays, doing cell culture, flow cytometry, ELISA, qPCR, and protein / DNA / RNA quantification.
Strong English reading and writing communication skills. French great asset.
GLP development of new methods, objectives, and strategies for cellular and immunology drug testing and validation.
Sample analysis and running of assays in a multidisciplinary lab setting.
Data analysis, report and protocol writing and SOPs.
Managing simultaneous projects with 3 to 4 analysts per project.
Implementation & Training Specialist, Drug Safety & Medical Information (Contract/Remote)
By Bayshore HealthCare At Mississauga, Ontario, Canada
Responsible for the development and implementation of Pharmacovigilance standard policies and procedures, in order to meet PSP PVA requirements.
Knowledge and understanding of Six Sigma concepts.
Professional degree in Health Sciences disciplines and/or Quality Compliance & Training Certification.
Minimum Three (3) years of previous experience driving and implementing training and quality compliance initiatives.
Experience in handling internal and external Pharma audits and/or board of health inspections.
Experience in handling root cause analysis, investigations and CAPA generation preferred.
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 Services Coordinator Jobs
By Canada Life At Winnipeg, Manitoba, Canada
Strong organizational, quality and time management skills
Experience working in Excel, Word and Access. Excellent keyboarding skills of 40wpm
Excellent analytical, investigative and problem solving skills
Excellent verbal and written communication skills
Knowledge of the insurance industry and exposure to drug plans will be considered an asset
Knowledge of BEN, TOCs, TSO and Cybrary will be considered an asset
Drug Safety Triage, Implementation & Training Coordinator
By Bayshore HealthCare At Mississauga, Ontario, Canada
Possess basic Project Management knowledge and skills.
Proficiency with standard desktop computing programs (Microsoft Office – Word, Excel, PowerPoint, Visio etc.) and CRM/data entry databases.
Experience with communication software and tools (e.g., SharePoint, online learning platforms, Microsoft Teams, Zoom etc.).
Excellent written, verbal, and facilitation skills.
Excellent organizational & critical thinking skills and proven attention to detail.
Excellent customer service skills to address queries from internal and external stakeholders.
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.
Drug Safety & Medical Information Coordinator
By Bayshore HealthCare At Mississauga, Ontario, Canada
a Day In The Life
Completes Other Tasks As Requested/required.
WHAT YOU BRING TO THE TEAM:
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.
System Owner In Medical And Safety Review Domain - Associate Director, Gcs
By AstraZeneca At Mississauga, Ontario, Canada
Demonstrated project management skills and proven skills to deliver to time, cost, and quality
Extensive experience of Quality Systems and Quality Management, including process definition and process improvement, ideally within an Information Systems environment
Service Management experience. Incident, Problem, Change and Release Management (ITIL)
Experience in the development and management of Business Process to deliver business performance
Experience in working successfully and collaboratively with external partners (vendors) delivering mutual benefit
Bachelor of Science (BSc) in a suitable discipline or equivalent experience