Triage of SAEs receiving from the site investigator through the eCRF.
Review of the reported SAEs and contact the site/CRO for more information, as required.
Work closely with the PVG CRO for case processing in the safety database.
Review approve the CIOMS including the SAE Narratives and update as needed.
Ensure reconciliation between the Safety database and the clinical database is done properly.
Involvement in safety documents writing submissions (e.g. DSUR, Periodic Line-Listing, SMPs SOPs)
Review of the reported SAEs and contact the site/CRO for more information, as required.
Work closely with the PVG CRO for case processing in the safety database.
Review approve the CIOMS including the SAE Narratives and update as needed.
Ensure reconciliation between the Safety database and the clinical database is done properly.
Involvement in safety documents writing submissions (e.g. DSUR, Periodic Line-Listing, SMPs SOPs)
Requirements:
At least 2 years' experience in Pharmacovigilance
Experience with Office tools (excel, word, Power Point), Acrobat
Fluent English (verbal writing)
Good communication skills
At least 2 years' experience in Pharmacovigilance
Experience with Office tools (excel, word, Power Point), Acrobat
Fluent English (verbal writing)
Good communication skills
This position is open to all candidates.
