Jatinder Singh, MD

Accomplished Clinical Pharmacologist with over 10 years of experience in drug safety, clinical practice and Academics. *Skilled in Pharmaceutics, Pharmacovigilance, Healthcare, Clinical Research, and Diabetes Care. *More than 4 years of experience in Pharmacovigilance. *6 publications in international journals. *Responsible for escalating urgent issues to line management and contributing in finding solutions. *Interacted and responded with appropriate client personnel independently to resolve issues related to literature reports and case analysis in accordance with clients’ requirements. * Actively involved in team mentoring, training & skill enrichment. *Conducted regular discussion and training sessions. *Monitored the safety profile of products including signal detection activities involving case analysis and literature review using SIDER. *Performed monthly quality review of statistically significant sample of cases in accordance with client requirements/conventions and standard operating procedures in software's like EMPRICA, EUDRAVIGILANCE, Trending analysis. * Updated and maintained signal detection plan. *Updated Annual literature search strategy for literature triage. *Analyzed medical information queries for safety information. * Attended safety team meeting and updating them of new safety concerns. Responsibilities as Medical writer *Expert in medical and scientific writing. *Provided support in preparation of Periodic Safety Update Reports(PSURs) *Provided medical advice to Drug Safety associates (DSAs) and specialists in medical aspects of drug safety *Provided support for the preparation of ad hoc reports, for short term notice requests *Literature triage review for PSUR inclusion/safety concern. *Have working knowledge of medical review of ICSRs of all types (spontaneous, clinical trials, solicited, discharge summaries, literature, pregnancy, special situations) *Knowledge of Triage of ICSRs, including determining the expectedness of adverse events against various labeling documents (SmPC, CCDS, IB, USPI, CCSI, etc) *Performed Post Authorization Safety Study classification and AESI Confirmation for various studies. * Performed Trial Master File Form review. *Performed Protocol review for various studies. *Performed Case narrative review for inclusion in various clinical study report (CSRs).