Pinal Modi Email & Phone Number

• Experienced physician with ten plus years of clinical research and pharmacovigilance experience. • Experienced physician working as safety product lead and contribute to safety surveillance and, benefit risk assessment and risk management plan development and maintain benefit risk profile of investigational and marketed compounds.• Expert in analysis of safety information for identifying signals from company or public database utilizing data mining techniques. • Experience working with IND/NDA application/filing• Experience in the preparation of responses to regulatory agencies and competent authorities including request for supplemental information (RSI).• Medical reviewer for clinical trial adverse events and spontaneous/solicited post marketing cases.• Experience working as Medical Monitor for the Clinical trial projects• Comprehensive knowledge of GCP/ICH and FDA regulations. • Experience in study design, protocol development and site management • Proven ability to lead and to manage safety/regulatory projects.• Strong and visionary leader with ability to identify and implement creative solutions, improve performance, and streamline procedures

Listed skills include Pharmacovigilance, Clinical Trials, Pharmaceutical Industry, Fda, and 10 others.