Anushruti
Drug Safety Analyst- Literature Specialist | Clinical research Specialist | PharmD | Scientific & Regulatory Writing|
- Role
- Senior Drug Safety Analyst - Literature Specialist at Wipro
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About Anushruti
Experienced Drug Safety Analyst with a strong background in literature searches, pharmacovigilance, summary writing, and clinical trial documentation. Currently working at Wipro India Pvt. Ltd. as a Literature Specialist, where I manage and execute comprehensive literature searches using databases such as PubMed, OVID, MEDLINE, and EMBASE to support safety surveillance and regulatory submissions. Skilled in developing search strategies, coordinating with external vendors, and ensuring compliance with PSUR and DSUR requirements. Proficient in creating and maintaining literature databases, writing summaries of findings, conducting ad-hoc searches, and ensuring timely and accurate data management for internal operations and audits. In previous roles at Ankura Consulting Group and Bioclinica, I conducted in-depth coverage analyses, managed clinical trial study databases, and tracked research-related expenses. I have extensive experience in quality control for vaccine case processing and in ensuring compliance with regulatory standards. My expertise also includes analyzing safety narratives, managing data acquisition processes, writing clear and concise literature summaries, and preparing comprehensive reports for regulatory submissions. I am proficient in tools such as EndNote, Mendeley, MedDRA, OnCore CTMS, and biomedical databases, with hands-on experience in literature database creation, scientific writing, and adverse event reporting.
Experience
Senior Drug Safety Analyst - Literature Specialist
Jan 2025 — Present
Education
Maharishi Markandeshwar University, Mullana
Doctor of Pharmacy - PharmD
2013 — 2019
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