Technical Officer Duties and Responsibilities:
- Regulatory
- As assigned, review product dossiers, as per verification and/or assessment procedures.
- Develop CRS assessment reports for eligible dossiers, and prepare comments for discussion as needed, in the context of CRS policies and relevant international guidance
- Conduct technical functions for regional pharmacovigilance and post-market surveillance, including data entry, case assessment, data analysis and communication of findings
- Support document organization and workload management, through updating of trackers, and filing of submissions and reports in the electronic system.
- Communications
- As needed, assist with operational communications with focal points of Member States and industry on regulatory matters (medicines registration, safety, quality).
- Assist to develop additional communications for CARPHA, CRS advisory team, PAHO advisors, regulatory focal points and industry representatives, where needed.
- Policy
- Review documents including international guidance to support development of policies and procedures
- Attend technical and/or policy meetings, as needed.
- Topics include, but are not limited to, any of the following: CARPHA/CRS medicine recommendations, safety monitoring, new processes, new policies, etc.
- Deliverables and oversight
- The associate will report to the Technical Coordinator of the CARPHA/CRS
- The associate will be paid for an equivalent of 20 hours of work per week.
- Work may be done virtually based on an agreed schedule, and approved by the Technical Coordinator
- The associate will be responsible for arranging time for the completion of assigned deliverables within the weekly timeframe
- The technical officer will submit periodic reports to account for work done, such as weekly reports on deliverables, monthly summaries of work done, and time-sheets to the Technical Coordinator.