Pharmacovigilance Associate

Responsibilities

• Data Entry of Individual Case Safety Reports (ICSRs) to the pharmacovigilance (PV) safety databases as per corporate and local requirements and timelines.
• Ensure that ICSRs for marketed products and medical devices subject to expedited reporting according to Canadian regulations are submitted to Health Canada within prescribed timelines.
• Monitor and support the preparation of written follow up requests to ensure timelines prescribed by local/global and corporate requirements are met.
• Perform reconciliations of the company's third party vendors programs, licensed partners as well as inter-departmental teams, as per corporate requirements and monitor key performance indicators.
• Provide support for the compliance monitoring of Individual Case Safety Reports (ICSRs) and generating metrics on case handling.
• Manage the external vendor training records including the launching of annual refresher training.
• Process Canada Vigilance queries and Access to Information requests/results.
• Support the analysis of reports in PV databases.
• Respond to queries and requests from internal and external stakeholders.
• Support the company's Project Leaders in compiling information for the LPSMF on a regular basis.
• Collaborate in developing and maintaining the local Pharmacovigilance standard operating procedures (SOPs), working instructions and job aids.
• Participate in the maintenance of the PV paper and electronic filing and archiving system according to corporate and Canadian requirements.
• Participate in the ongoing optimization of PV procedures as well as inter-departmental procedures affecting PV.
• Provide overall support to PV team activities.