The Pharmacovigilance Associate will provide service to both external customers and also support internal management
Skills & Experience
- 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 and/or RA Diploma with at least three years of previous Pharmacovigilance experience is required
- 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
Specific responsibilities include:
- Conduct duplicate searches in database and enter new adverse events after careful validation.
- Assess adverse events and determine if they qualify for expedited reporting.
- Perform medical review of ICSRs and generate follow-up questions.
- Literature assessment for ADRs and medical review of articles.
- Conduct causality assessments for safety cases reports.
- Liaise with Global safety officer and affiliates for improvement in products safety.
- MedDRA coding assessment.
- Perform expectedness and listedness assessment and ICSR reportability as per label and Product Monograph.
- Conduct quality review of ICSRs.
- Submission of ICSR to health authorities
- 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.
- Respond to queries from clients and handle safety mailboxes.
- Perform reconciliations of reports as required.
- Evaluate complaint reports for accuracy and maintain a Pharmacovigilance system
- Review Canada Vigilance database
- Support in preparing for PV inspections and audits as required and execute the necessary corrective actions
- Conduct medical reviews for all documents and assess them for scientific validity and accuracy
- Conduct literature reviews and summarize complex evidence; assist with educational resources for HCPs
- Coordinating and preparing product and disease state training for different audiences
If this opportunity is of interest to you and are looking to working in a small company with growth opportunities, we would like to speak to you.
While we appreciate the interest of all applicants, only candidates selected for an interview will be contacted.
No agencies, please.