Pharmacovigilance Specialist

Responsibilities

• Collaborate in maintaining an efficient vigilance system in compliance with the Health Canada regulations and guidelines, participating in other Pharmacovigilance (PV) processes and ensuring appropriate contacts with internal and external stakeholders.
• Collect, pursue follow-up information to complete quality adverse event reports and transmit all local adverse events to Global Pharmacovigilance (GPV).
• Document and update case information into the PV safety database as as per Good Documentation Practices (GDPs).
• Analyze and process adverse events and safety reports with utmost quality and timeliness in accordance with Global and Local PV procedures.
• Respond to queries and requests from internal and external stakeholders.
• Evaluate domestic and foreign ICSRs (marketed and non-marketed drugs) for submission to Health Canada according to Canadian regulations and within prescribed timelines.
• Collaborate in developing and maintaining the local Pharmacovigilance standard operating procedures (SOPs), work instructions and job aids.
• Provide support in the Periodic Safety Report activities in accordance with Canadian regulations and corporate procedures.
• Support activities involving product launch, risk management plans, studies, safety queries, handling product alerts, and review of product monographs and protocols.
• Provide support in the maintenance of Canadian product list and reporting rules for PV database configuration.
• Support local literature review activities including oversight of the review performed by global vendors, maintaining lists of journals and products, and handling literature-related queries.
• Provide training and on-going support as well as perform quality assurance and quality control for work delegated to the global PV vendors (CPOC, i.e. Country PV Operating Center) and addressing issues.
• Provide support for Signal Detection and Local Safety Surveillance activities in accordance with regulatory and corporate requirements.
• Maintain current knowledge of all relevant local Pharmacovigilance regulations for Sanofi marketed products.
• Educate internal and external stakeholders on the implications of existing PV regulations and guidance documents along with local and global procedures and policies.
• Provide support in monitoring compliance with Canadian and foreign case management activities and implement corrective and preventative actions involving the PV team.
• Participate in the ongoing optimization of PV procedures as well as inter-departmental procedures affecting PV.
• Provide overall support to the PV team activities.