- Collect and forward adverse events reports (ICSRs) for initial, follow-up, serious, non-serious, solicited, non-solicited cases to GPV (Global Pharmacovigilance) or licensed partners as per corporate and local requirements and timelines.
- Prepare written follow-up requests for ICSRs as per corporate and local requirements
- Document in the Global PV database all activities related to Canadian ICSRs.
- Manage the regular reconciliations with service providers.
- Manage the external vendor training records including the launching of annual refresher training.
- Support the Sanofi PV Lead in compiling information for the LPSMF on a quarterly basis.
- Contribute to the development and organization of a local quality system (SOPs) supporting Associate Pharmacovigilance activities.
- Participate in the ongoing optimization of PV procedures as well as inter-departmental procedures affecting PV.
- Participate in the maintenance of the PV filing and archiving system according to corporate and Canadian requirements.
To apply for this job please visit www.brunel.net.