Pharmacovigilance and Medical Information Associate

Job summary

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.

Job details

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.

What you’ll do

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.

Listed skills

• Microsoft Office · Preferred
• Project management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• 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

Job areas

• Healthcare
• Science & Research
• Legal
• Management & Leadership

More jobs from Xediton Pharmaceuticals Inc.