I have over 5 years of experience in field of Pharmacovigilance Management with an immense knowledge of narrative writing for Clinical Study Report (CSR). I have lead and managed approximately 5-6 studies in multiple therapeutic areas (Oncology, Respiratory complications, Visual defects, and Rheumatology), which includes both pre- and post-marketing studies, at the same time thereby delivering high quality narratives within set timelines. I have an expertise in drafting the template for narratives, preparing clear and accurate narratives based on clinical and safety database, and performing Quality Check of narratives to ensure high quality of the safety reports in accordance with client SOPs and regulatory requirements. Apart from narrative writing, I have coded approximately 1500 cases - ICSRs of all case types (spontaneous, clinical studies, and solicited programs).