PHARMACOVIGILANCE SPECIALIST

1. JOB OBJECTIVES

• Management of requests for medical information and reports of adverse effects and complaints concerning Juno Pharma Canada products.
• Preparation of summary and periodic pharmacovigilance reports for products by documenting the adverse effects reported.
• Maintain ongoing compliance with Health Canada requirements for pharmacovigilance and drug safety and, other Health Authorities in countries where Juno Pharma Canada Inc. sells products.
• Design and deliver pharmacovigilance GMP training and materials to Juno Pharma Canada employees.
• Provide technical support to clients/patients.

2. PRINCIPALES FONCTIONS/ PRIMARY FUNCTIONS

• Prepare summary and periodic pharmacovigilance reports (PSURs) according to Canadian regulations and ICH standards for marketed products.
• Answer technical questions and/or customer complaints regarding marketed products.
• Document adverse effects reported by healthcare professionals, customers or according to the literature for marketed products in order to communicate them to the authorities involved, when necessary.
• Conduct inspections and audits of third parties who distribute Juno Pharma Canada products and, when inspected by clients, partners or Health Authorities, respond to the observations report and implement the necessary changes.
• Provide training for new employees, consultants, and annual training for all company personnel.
• Cooperate in the event of products recalls.
• Prepare, revise and implement Standard Operating Procedures (SOPs).
• Write and update various internal documents.
• Verification of leaflet and monographs of marketed products.
• Perform all other related tasks deemed relevant to this position.