Work Experience Summary
• Over 13 years' experience within Pharmaceutical Research & Development (R&D) in Clinical operations, Medical writing and Pharmacovigialnce, in particular clinical drug development, Phase I-IV clinical trials, post marketing drug safety, pharmacovigilance activities and regulatory compliance.
• Clinical trial Project Management experience in various therapeutic areas, like Oncology, Endocrinology, Gastroenterology, Cardiovascular, Dermatology, Infectious diseases, Neurology, Immunology, Orthopedics, Respiratory and Metabolic disorders
• Several years of CRA experience in Study Feasibility, Site Monitoring, Site Selection experience and site close out activities.
• Medical & Scientific Writing activities- Preparation and review of Protocols, Investigators Brochure, Clinical Study Report, Patient Documents like Informed Consent Forms, Review Articles, Manuscripts, Case Studies and Conference Abstracts.
• Design and conduct of early and late phase research studies and cohort studies
• Conduct of Post marketing surveillance/safety observational studies to generate real world outcomes data.
• Design of the Observational Research studies including large scale prospective observational studies, database studies, or chart reviews.
• Regulatory support: IND/Phase I Clinical Trials dossier submissions, Phase II, III and IV clinical trials approvals for drugs, Pilot and pivotal studies approvals, Import licenses for investigational pro