- Forward ICSRs (initial, follow-up, serious, non-serious, solicited, non-solicited, drug, medical device) to GPE (Global Pharmacovigilance and Epidemiology) or licensed partners as per corporate and local requirements and timelines.
- Process CIOMS reports received from GPE for domestic and international cases in preparation for evaluations by PV specialists. Following evaluations by PV specialists, process reports for submitting to Health Canada.
- Ensure that all ICSRs for drugs and medical devices subject to expedited reporting according to Canadian regulations are submitted to Health Canada within prescribed timelines. PV specialists will identify such ICSRs as well as deadlines.
- Prepare written follow-up requests for ICSRs as per corporate and local requirements.
- Document in the local PV tracking database (Remedy) all activities related to Canadian ICSRs and international reportable ICSRs.
- Process medical device ICSRs and PTCs (Product Technical Complaints) as per local and corporate requirements, including ICSRs from the Lantus Pen Call Centre. Maintain paper and electronic filing of such activities, including data entry in the local PV tracking database.
- Maintain paper files for all PV activities as per Canadian and corporate requirements and according to GDP (Good Documentation Practices).
- Maintain an accurate and efficient electronic filing system for all PV activities to ensure efficient functioning of the team.
- Participate in the administration of the PV tracking database (Remedy) including modifications, corrections, and adjustments for continuous improvement of the system.
- Participate in the development of quality documents (e.g., working documents) describing the technical steps of coordinator activities.
- Provide overall support to the PV team, including the PV Head and PV specialists, on all team activities
To apply for this job please visit www.brunel.net.