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Added 19 mins ago
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Senior Associate (m/f/d) Equity Index Client Operations
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Toronto, ON
- Full-time
The best client relationships are built on trust, responsiveness, and consistent execution. As a Senior Associate in Equity Index Client Operations (EICO), you will be a key partner to…
Added 1 hour ago
TH
Lumber Sales Associate Part-Time - 7180 Winnipeg North
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- Part-time
…are familiar with related items in order to sell an entire project. Associates in this position know how to greet, engage, and thank every customer in their department and know how to…
Added 2 hours ago
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Added 4 hours ago
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London, ON
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Added 5 hours ago
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Added 6 hours ago
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Research Associate In Organic Synthesis
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Added 6 hours ago
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Associate Director Quantity Surveyor
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Manager, Real Estate Operations
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AI DevOps Specialist (AI Enablement & Secure DevOps)
Experis
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- Contract
● Multi-Phase Sandbox Rollout: Own the deployment and lifecycle management of the HPS AI Sandbox environment across cloud and hybrid infrastructures.
Added 10 hours ago
P
Client Services Associate - January 2027
proSapient
Toronto, ON
- $55,000 to $75,000 CAD / year
- Full-time
As a Client Services Associate, you'll act as the link between our clients and the expert knowledge they seek. You will manage multiple parallel workstreams from dealmakers, strategists,…

Xediton Pharmaceuticals Inc.

Pharmacovigilance and Medical Information Associate

Oakville, ON, Canada

Full-time

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Job details

Job type: Full-time
Apply by: Apr 4, 2027
Posting language: English
Posted: Oct 6, 2026

Original job description

Company Description:

Xediton is a specialty pharmaceutical company focused on meeting the needs of patients, physicians, and partners. We are committed to developing, partnering, and making available new and established medicines to promote the health of Canadians. We are located in Oakville, Ontario. For more information, please visit www.xediton.com.

Pharmacovigilance and Medical Information Associate

Job Description & Key Responsibilities

Xediton is seeking an energetic, self-motivated and scientifically driven Medical Affairs Associate to support the Medical & Scientific Affairs team. The successful candidate will contribute to scientific, educational, operational and compliance activities while working closely with internal and external stakeholders.

Specific responsibilities include:

Triage and evaluate ICSRs for validity, seriousness and reportability.
Prepare and submit adverse event reports (CIOMS) to partner and Health Canada as per Pharmacovigilance agreement in a timely manner
Conduct causality assessments for safety cases reports and liaise with Global safety officer and partners for improvement in product safety.
MedDRA coding assessment
Evaluate pharmacovigilance reports and maintain a pharmacovigilance system
Selecting and screening of journals for performing Literature searches for adverse events.
Screening Canada Vigilance Database for retrieval of the ICSRs for company products and reporting to Health Canada and Partners as per PV agreement and Health Canada Guidelines.
Performing Reconciliation with Business partners as Pharmacovigilance Agreements
Identifying and reporting unusual failures in efficacy reports to Health Canada.
Assist in the preparation, review and evaluation of signals, aggregate reports (PSUR and PBRER) risk management plan as per Product requirements.
Generate responses to regulatory authority requests on product safety related issues for marketed products or products in development.
Support in preparing for PV inspections and audits as required and execute necessary corrective actions
Conduct medical reviews for all documents and assess them for scientific validity and accuracy
Ensure clinical and scientific information provided is accurate, fair, balanced and based on current medical literature and practice
Conduct literature reviews and summarize complex evidence; assist with educational resources for HCPs
Coordinating and preparing product and disease state training for different audiences
Support Business Development in product evaluation and assessment; review all sales and marketing material for scientific accuracy

Skills & Qualification:

The successful candidate is a highly motivated, enthusiastic and dynamic team player who is resourceful and dedicated and has competencies in adapting to changing environments.

Competencies:

University Science Degree with at least three years of previous Pharmacovigilance experience
Thorough understanding of Canadian Regulatory requirements, including interpretation of the Food & Drug Act and Regulations and a working knowledge of ICH requirements.
Knowledge of Canadian GMPs and Pharmacovigilance
Applies good document management practices.
Solid working knowledge of Pharmacovigilance
Proficient computer skills, which would include Microsoft Office (Word, Excel, Outlook)
Excellent communication skills (written and oral)
Superior organizational skills, with the ability to prioritize and handle multiple tasks and deadlines, works well under pressure and has a sense of urgency
The successful Candidate will possess excellent attention to detail and have the ability to manage time and complex PV projects.
Self-starter who is able to work independently with minimal supervision

Salary Range: 65k – 70k

If you are ambitious, scientifically driven and looking to be part of a growing specialty pharmaceutical company, we would like to hear from you. To apply, please visit www.xediton.com and email your resume and cover letter to hr@xediton.com.

While we appreciate the interest of all applicants, only candidates selected for an interview will be contacted. Xediton Pharmaceuticals Inc. is committed to fostering an inclusive and accessible workplace. Accommodations are available throughout the recruitment and selection process upon request. We review all applications through a fair, human-led process and do not use artificial intelligence (AI) to screen or make hiring decisions on resumes.

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More about this job

Responsibilities

Triage, assess, code, and report adverse event cases, maintain pharmacovigilance systems, and support safety activities including literature screening, signal evaluation, aggregate reports, risk management plans, audits, and regulatory responses. Review medical and promotional materials for scientific accuracy, summarize evidence, develop educational and training resources, and support product evaluations with internal and external stakeholders.

Requirements

Requires a university science degree and at least three years of pharmacovigilance experience, with a thorough understanding of Canadian regulatory requirements and working knowledge of ICH requirements and Canadian GMPs. Candidates should have strong communication, organizational, document management, computer, and time-management skills, with the ability to manage complex projects independently and meet deadlines.

Skills

Pharmacovigilance
Adverse Event Case Triage
Causality Assessment
MedDRA Coding
Regulatory Reporting
Canadian Regulatory Requirements
ICH Requirements
Literature Review
Signal Detection
Aggregate Reporting
Risk Management Planning
Medical Review
Scientific Communication
Document Management
Microsoft Office
Project Management

Visa sponsorship

Not detected in the job text

Keywords

Pharmacovigilance
Medical Information
Medical Affairs
Individual Case Safety Reports
CIOMS
Health Canada
Causality Assessment
MedDRA
Canada Vigilance Database
Pharmacovigilance Agreements
Literature Searches
Signal Evaluation
PSUR
PBRER
Risk Management Plans
Regulatory Authority Requests
Pharmacovigilance Inspections
Pharmacovigilance Audits
Corrective Actions
Medical Review
Scientific Validity
Clinical Information
Medical Literature
Healthcare Professional Education
Product Training
Business Development
Sales and Marketing Material Review
Food and Drugs Act and Regulations
ICH Requirements
Canadian GMPs

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