Keywords
Clinical Works
Pharmacovigilance
Databases
Labeling
Gap Analysis
Structured Product
Triage
Argus
Safety Principles
Skills
I had 4+ yeasr of experience in Pharmacovigilance and Regulatory affairs.
- ICSR Case Reports - Triage, Processing into database like Argus, PcV Manager and other safety databse, Quality review and Submission.
- Monitoring of Medical Literature- Screening and Processing of Literature Reports
- Preparation of PSURs, PADER and ASR reports
- Product Registration support: NDAs, ANDAs and other global registration applications
- Preparation of Clinical and Non-clinical Module documents
- Dossier Preparations and Gap Analysis
- Structured Product Labeling (SPL)
- Conversion of Dossiers (Paper / NeeS / eCTD)
Project history
- Processed nearly 2000 ICSR cases of Both Serious and NS for various Regulatory Authorities like USFDA, EMA and TGA etc.
Local Availability
Only available in these countries:
India
