Pharmacovigilance and Medical Information Associate

Xediton Pharmaceuticals Inc.; Oakville; On-site; CAD 65,000 - 70,000; Full time

Job summary

Xediton Pharmaceuticals Inc. is seeking a Pharmacovigilance and Medical Information Associate to support the Medical & Scientific Affairs team in Oakville, Ontario.

You will contribute to safety, regulatory, and medical information activities, ensuring accuracy and compliance across the product lifecycle. Responsibilities include evaluating safety data, preparing adverse event reports for Health Canada, conducting causality assessments, literature reviews, and supporting PV inspections and

Qualifications

• University degree with PV experience
• Knowledge of Canadian regulatory requirements (Food & Drug Act & Regulations)
• Knowledge of Canadian GMPs and Pharmacovigilance
• Solid working knowledge of Pharmacovigilance
• Excellent written and oral communication skills
• Independent worker with strong time-management under pressure

Responsibilities

• Triage and evaluate ICRS for validity, seriousness and reportability
• Prepare and submit adverse event reports (CIOMS) to Health Canada per PV agreement
• Conduct causality assessments for safety cases and liaise with Global safety
• MedDRA coding assessment
• Evaluate PV reports and maintain PV system
• Literature screening for adverse events and summarize evidence
• Prepare for PV inspections and audits and implement corrective actions
• Generate responses to regulatory requests on product safety issues

Skills

Excellent communication

Organizational skills

Self-starter

PV system knowledge

Proficient computer skills

Education

University Science Degree

Tools

Microsoft Office

Job 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 ICRS 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 ICRSes 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.

• 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
• 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

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.