Position : Aggregate Report Writer

These team members at multiple levels (Specialist/Associate Team Lead) will be recruited at FHS PV unit (for writing PSUR and other PV reports). All these employees would be having expertise and experience in preparation of aggregate reports with reputed PV firms.

Experience : 1- 3 years in aggregate report writing; experience in ARISg and ARGUS

Educational background: B. Pharm; M. Pharm, BHMS/ BAMS/ BDS

General Technical responsibilities
Preparation and submission of aggregate reports i.e. Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Adverse Drug Experience Reports (PADERs)
Reporting of periodic cases to USFDA
Maintaining documentation and archival of PSURs