Tanya Chaudhary

Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.

Senior medical writer with 5 year of experience in medical writing and total10 years in pharmacovigilance. Proven track record and expertise in authoring and reviewing safety evaluation reports (SERs), various Regulatory reports such as PBRERs, DSURs and RMP. Expertise in responding to regulatory questions, regulatory compliance and drug safety assessment. Experienced in structured Benefit-Risk assessment (sBRA) for PBRERs, ad hoc requests and regulatory submissions. Expertise in triage and coding ICSRs (5 years of experience) of various case types (spontaneous, clinical studies, solicited programs and literature cases). 

• Experience in safety signal management process (signal detection, prioritization, validation, evaluation, analysis, and assessment) including review of data from various sources - PV database, Literature, Epidemiology, VigiBase, FAERS and EudraVigilance data.
• Well versed in authoring signal evaluation reports with expertise in handling Health Authority requests.
• Experienced in preparing various sections of aggregate reports including PBRERs, DSURs and RMP
• Specialization in performing structured Benefit-Risk Assessment (sBRA). Worked in close collaboration with the medical, regulatory and PV functions to support benefit-risk conclusion.
• Expertise in literature triage as well as literature summarization for aggregate reports.
• Responsible for leading various cross functional team meetings as subject matter expert for assigned product. Ensured prompt delivery of high-quality work in collaborative working space.
• Responsible for performing quality control (QC) on the reports prepared by the team.
• Involved in preparing and updating the training content for new medical writers and responsible for mentoring to ensure best practises are followed.
• Expertise in management of ICSRs of various case types including triage of ICSRs, coding of literature ICSRs in the safety database, writing case summaries, performing causality assessment and writing company comment if required.

Kumar, A., Chaudhary, T., Minocycline modulates neuroprotective effect of hesperidin against Quinolinic acid induced Huntington’s disease like symptoms in rats: Behavioural, biochemical, cellular and histological evidences, European Journal of Pharmacology, 720(1-3), 16-2, 2013