Darshit Patel

Biography

• Preparation of Aggregate Reports including Periodic Adverse Drug Experience Reports (PADERs) for US FDA and Periodic Safety Update Reports (PSURs) as per the guidelines and company’s controlled documents (e.g. SOP and work instruction). • Compilation of data for Aggregate Reports including Line Listing and Summary Tabulation. • Responsible for management and timely submission of aggregate reports in order to achieve 100% compliance.

Research Interest

Regulatory Affairs,Pharmaceutical industry,