Ramisetty Sireesha

I’m a pharmacy graduate (M. Pharmacy, Pharmaceutics) with hands-on internship and review experience across clinical research, pharmacovigilance, and medical writing. I’m eager to apply my scientific training to support healthcare teams and improve patient outcomes.

In clinical research, I’ve worked with study concepts from drug discovery through clinical trial phases, including protocol and report preparation, ICH and Good Clinical Practice (GCP) understanding, and knowledge of trial documentation such as Trial Master File/eTMF, ICFs, and CRFs. I’m comfortable working across centralized and decentralized trial responsibilities and timelines.

For drug safety, I’ve built a foundation in PV workflows, including AE/ADR/SAE definitions, ICSR processing, causality assessment approaches (WHO UMC and Naranjo), and regulatory knowledge such as 21 CFR 312 & 314 and ICH E2A-F/CIOMS principles. I also understand aggregate reporting concepts (DSUR/PSUR/PBRER) and tools like Argus database.

As a Copyediting Reviewer at Cactus Communications, I strengthened my attention to scientific detail by editing research articles and manuscripts while ensuring compliance with regulatory timelines. I also contribute to academic-style outputs—thesis, manuscripts, posters, and systemic literature reviews—bringing clarity, structure, and quality to complex scientific data.