The Pharmacovigilance (PV) Assistant’s main tasks will be:
- to receive and return safety messages and acknowledgement receipt
- to carry out ICSR local regulatory reporting
- to submit PSURs
- to track PSUR submission
- to track and file ICSRs
- to archive, distribute SOPs and maintain SOP index
- to prepare documents’ final lay out
- to organize meetings and teleconferences
- to assist the organization of PrimeVigilance offices
Line Management:
- the PV Assistant will report on a day to day basis to the Pharmacovigilance Manager and also directly to the Director of Operations
Other supportive responsibilities
The PV Assistant will assist PrimeVigilance senior Management on an as needed basis.