Shilpa Sharma

WORK HISTORY

EDUCATION

ABOUT SHILPA SHARMA

Results-driven medical professional with 17 years of experience in the pharmaceutical industry, specializing in medical writing, clinical trials, and pharmacovigilance. Proven track record of delivering high-quality work and ensuring compliance with regulatory requirements.Professional ExperienceMedical Writer/Clinical Trials Medical Monitor/Pharmacovigilance Specialist- Sun Pharma (2015 - Present)- Ranbaxy (20••••15)- Developed and implemented medical writing strategies for clinical trials and regulatory submissions - Managed clinical trials, ensuring compliance with GCP and regulatory requirements - Medical Monitor for various trials in different therapeutic areas conducted in India and globally - Conducted pharmacovigilance activities, including aggregate reporting, Health hazard evaluations, signal detection and risk management - Collaborated with cross-functional teams to ensure project timelines and deliverables were met - Led automation project for signal management, successfully transitioning to LSSRM signal software, resulting in improved efficiency and accuracy Education- MD, Pharmacology, Kasturba Medical College, MAHE (2008)- MBBS, Kasturba Medical College, MAHE (2003)Skills- Medical writing and editing- Clinical trial management and monitoring- Pharmacovigilance and risk management- Regulatory affairs and compliance- Strong analytical and problem-solving skills- Signal detection and management- Automation project managementAchievements- Successfully managed medical monitoring activities for numerous clinical trials, ensuring timely completion and regulatory compliance- Developed and implemented effective pharmacovigilance strategies, resulting in improved safety monitoring and risk management- Business Lead for automation of Signal process with successful transition to LSSRM signal software-Using Advanced Analytical Tools and data analytics PV Lead in Global Clinical development of NCE products