Sima Patel

Background

About Sima Patel

I am experienced Pharmacovigilance Professional. I have >12 year of hand on expertise in managing day to day Pharmacovigilance activities which includes, ICSR handling, Literature Review, Aggregate reports (PSUR, PBRER, PADER) development, Signal Detection and Risk Management, Pharmacovigilance SOP / Processes development, Health Authorities Inspection coordination, Vendor audits and self inspections and Contracts / agreement development. My involvement in numerous audits and inspections enables me to be the best at what I do at all times. My extensive exposure to MHRA and Health Canada inspections has given me hands on experience to obtain an enhanced level of understanding to meet the requirements to achieve a robust pharmacovigilance system. I possess effectual oral and written communication skills and work well in pressured environments. I have exceptional organizational and planning skills. I am a well motivated individual and work well within predefined timelines and under pressure. My past experience has also helped me gain the ability to demonstrate excellent attention to detail; self manage my projects and time. Specialties Pharmacovigilance, ICSR Handling, Literature Review, Aggregate Report Development (PSUR, ASR, PBRER and PADER), Signal Detection and Risk Management, Pharmacovigilance Audits, Health Authorities Inspections, PVG In-house database validation (PQ), Training, PV SOP Development, Contracts / agreement development