Job Details

Job Summary
The Bilingual Pharmacovigilance (PV) Specialist is an integral part of the pharmacovigilance team, and is responsible for the identification, collection, documentation, processing and reporting of adverse event data in compliance with Health Canada regulations and client specific requirements.

The Bilingual PV Specialist will ensure accurate and comprehensive data entry of adverse event information in a timely manner. They are also responsible for supporting the pharmacovigilance team in activities related to quality safety reviews, internal pharmacovigilance auditing, and deviation investigation & management.

Specific Responsibilities

• Management of adverse events from all relevant sources
• Ensure all adverse events are processed in a timely manner according to client requirements
• Demonstrate diligence in follow-up attempts to ensure all necessary information for case completeness
• Ensure adequate documentation and archiving of all drug safety information and source documentation
• The ability to accurately record and represent relevant information from medical and diagnostic reports and prepare concise narrative summaries of safety information
• The ability to work independently across multiple projects and work collaboratively with other team members and colleagues across disciplines
• The ability to follow established processes and the flexibility to adopt new practices and priorities as required
• Work with clients, as required, to ensure processes and strategies are maintained, internal and external timelines are met, potential issues are communicated, and resolution is achieved in a timely manner
• Support inspection readiness and audits as required
• Manage activities in specific projects as assigned

General Responsibilities

• Ability to prioritize and reprioritize work in a constantly changing environment
• Adhere to professional standards as stipulated by the relevant governing professional bodies
• Participate and assist in departmental continuous improvement activities related to process, quality, and training
• Assist with reviews of aggregate data to identify program trends and communicate these trends appropriately
• Maintain program data integrity through the quality review of program documentation, ensuring completeness and accuracy
• Perform other duties as assigned

Competencies

• Healthcare professional experience (licensed HCP in Canada) is required
• Bilingual in English and French is an asset
• Previous experience in pharmacovigilance activities an asset
• Proficiency in Microsoft Office programs (Word, Excel, Outlook)
• Attention to detail and excellent organizational skills