Under the general supervision of the Group Lead, Vaccines Assessment PQT, the incumbent will carry out the following duties:
1. Screen files submitted for prequalification evaluation and liaise with vaccine focal points and clinical assessors to decide acceptance or rejection of the file. Communicate outcomes to the manufacturer following the established procedures.
2. Screen Vaccine Product Annual Reports and liaise with vaccine focal points and clinical assessors to advise of required further evaluation activity, where applicable.
3. Review updated information on labelling and inserts received from manufacturers and liaise with the appropriate staff to ensure the updates are fully evaluated and reflected on the website.
4. Review technical documents within his/her field of expertise (i.e. Good Manufacturing Practice (GMP) related).
5. Support activities related to the implementation of the collaborative review procedure for registration in receiving countries of imported prequalified vaccines.
6. Input the information from item five into the web-based database in timely manner.
7. Collaborate with the review of files during the file review weeks and participate in inspections and support GMP experts in such missions.
8. Undertake other activities under the guidance of the Vaccines Assessment Group Lead.