Company Description:
Xediton is a specialty pharmaceutical company with a focus on meeting the needs of patients, physicians and partners. We are located in Oakville, Ontario.
Pharmacovigilance and Medical Information Associate
& Key responsibilities:
The Pharmacovigilance Associate will provide service to both external customers and also support internal management.
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.
Educational Qualification
University Science Degree with at least three years of previous Pharmacovigilance experience
Competencies:
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
If this opportunity is of interest to you and are looking to working in a company with growth opportunities, we would like to speak to you .
To apply, please email your application and resume to
While we appreciate the interest of all applicants, only candidates selected for an interview will be contacted.
No agencies, please.