Dhanashree Jathar

About Dhanashree Jathar

With over a decade in the pharmaceutical industry, my mission is to ensure drug safety…

Experience

1. Assistant Manager

   Apotex India

   Aug 2021 — Present · Mumbai, IN

   Lead and manage a team of 10 medical writers, overseeing onboarding, workflow and work allocations, conducting appraisal discussions, and setting goals and ratings for team members• Developed an editorial Style Guide for scientific writing, aligning with regulatory and GDP principles, resulting in reduction in GDP errors and significantly improving report quality• Prepare and review Periodic Safety Update Reports (PSUR)/ Periodic Benefit Risk Evaluation Reports (PBRER)/ Periodic Adverse Drug Experience Reports (PADER)/ Risk Management Plan (RMP)/ Signal Assessment Reports for regulatory submission• Monitor safety issues and conduct literature reviews, demonstrating strong scientific skills• Respond to complex safety information queries from Regulatory Authority, Quality and Audit• Knowledge of authoring Corrective Action Preventive Action (CAPA) • Ensure compliance with global policies, including ethics, quality• Develop and maintain SOPs and training documents, track compliance of global partners• Maintain knowledge of SAP, ARGUS and MedDRA terminology