Pharmacovigilance Specialist

Responsibilities

• Analyze and process adverse events and safety reports with utmost quality and timeliness in accordance with Global and Local Pharmacovigilance procedures.
• Collect, pursue follow-up information to complete quality adverse event reports and transmit all local adverse events to Global Pharmacovigilance.
• Evaluate domestic and foreign ICSRs (marketed and non-marketed drugs) for submission to Health Canada according to Canadian regulations and within prescribed timelines.
• Submit the Canadian reportable adverse reactions to Health Canada according to their regulations and guidance's.
• Respond to queries and requests from Global Pharmacovigilance.
• Run monthly submissions compliance report and communicate with team members.
• Organize and ensure maintenance of the electronic filing and archiving system according to corporate and Canadian requirements.
• Document and update case information into the global safety database.
• Interact with other functional areas/departments to process adverse events efficiently & reliably.
• Collaborate in developing and maintaining the local Pharmacovigilance SOPs and procedures.
• Update the list of all Canadian drug licensing status and renewals, in conjunction with Regulatory Affairs.
• Participate in training of PV Associate on their assigned activities.
• Support associate with inbound and outbound case management activities as needed and as per corporate and local requirements and timelines.
• Provide overall support to the PV on all team activities.
• Maintain current knowledge of all relevant local Pharmacovigilance regulations in regard to drug, natural health and cosmetics products.
• Coordinate responses to questions and requests from Regulatory Authorities.