The Safety Surveillance Physician will implement and support further development of proactive and systematic product surveillance strategies, including alert triage, signal validation, and safety data analysis.
Responsibilities
Performance of alert triage within pre-defined timelines, by conducting systematic reviews of cases and aggregate data in the safety databases and reviewing trends to identify potential safety signals.
Performance of signal validation and support for signal evaluation through the review, analysis, interpretation, and summary of case and aggregate safety data from various sources such as clinical, post marketing, observational studies, medical literature, health authority databases, and product quality databases.
Assistance in the development and implementation of strategies for the surveillance of post-marketing data, as well as the development of product-specific medical safety
Participation as a member of the matrix teams to address product-specific safety
Support for the evaluation of novel and computer-assisted tools and methodologies for the analysis of safety data.
A scientifically oriented subject matter expert responsible for reviewing important and pre-specified medical data in clinical trials (focus on late phases) to ensure data integrity and participant safety.
Responsibilities
Reviewing important and pre-specified medical data in clinical trials (with focus on late phases)
Work closely with study teams (Global Clinical Lead, Global Study Leader, Principal Study Data Manager, Study Statistician, and Statistical Programmer)
Ensure well-defined standards are outlined during the study and relevant documents and tools are in place
Involve in design, conduct, monitoring, data interpretation, and reporting of individual clinical trials
A Health & Safety Regional Specialist responsible for health and safety activities and applicable legislation in the Atlantic region, specifically supporting the Port Coquitlam and Abbotsford facilities.
Locations (2)
Port Coquitlam, British Columbia, Canada
Abbotsford, British Columbia, Canada
Compensation
$92,795 - $121,795
Responsibilities
Collaborate closely with peer group in executing company safety policies by providing training and education to ensure that employees follow Corporate and Governmental Safety Standards
Work in collaboration with the Corporate Health & Safety team as well as other Health & Safety Specialists to foster and promote a culture of employee engagement and continuous learning
Influence change through comprehensive risk assessments and safety data analysis and proactively review and execute safety programs
Conduct system-based risk reviews, energy hazard assessments and routine control verifications
Provide guidance and review of site incidents in developing supervisor’s skills in investigating and preparing detailed reports with strong corrective actions
Requirements
Degree/diploma in Health and Safety or equivalent
Nice to have: CRSP (Canadian registered safety professional)
Health and Safety Manager, HKGNewAmazon · Hong Kong, Hong Kong SAR
Safety Surveillance PhysicianNewClinChoice · Pasig City, Philippines
Senior Medical Reviewer (Alexion)AstraZeneca · Warsaw, Poland