- Responsible for the oversight of Brunel staffs local PV activities.
- Ensure smooth operation of case management activities to maintain compliance with corporate and Canadian regulatory reporting requirements.
- Assess needs, optimize, and ensure maintenance of the PV procedures according to corporate and Canadian requirements.
- Monitor workload and oversee assignment of tasks to ensure compliance with corporate and Canadian requirements.
- Compile case management metrics on a monthly basis and analyze/communicate any trends.
- Train, supervise and coach 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.
- Assess needs, organize and ensure maintenance of the electronic filing and archiving system according to corporate and Canadian requirements.
- Evaluate domestic and foreign ICSRs (marketed and non-marketed drugs) for submission to Health Canada according to Canadian regulations and within prescribed timelines.
- Contribute to the development and organization of a local quality system (SOPs) supporting all Pharmacovigilance activities.
Post-market surveillance activities:
- To collect, pursue follow-up information to complete quality adverse event reports and transmit all local adverse events to Global Pharmacovigilance.
- To document and update case information into the global safety database.
- Analyze and process adverse events and safety reports with utmost quality and timeliness in accordance with Global and Local Pharmacovigilance procedures.
To apply for this job please visit www.brunel.net.