I've 4+ years of experience in Pharmacovigilance.

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)