Sruthi Reddy C.

About Sruthi Reddy C.

With 4+ years of experience in medical writing and pharmacovigilance, I transform complex safety data into clear, actionable insights that protect patients worldwide. At Sanofi, I specialize in periodic safety reporting, managing electronic document submission (eDS) activities, coordinating product alerts, and driving projects that keep our teams compliant and aligned. My focus? Ensuring critical safety information reaches regulators on time, every time.I\'m passionate about advancing pharmaceutical safety through innovation and collaboration.

Experience

1. Project Specialist-periodic Report Expert (Pre)

   Sanofi

   Nov 2024 — Present · Hyderabad, IN

   To evaluate the benefit-risk profile of marketed medicinal products to provide safe and effective medicines to patients. To support the preparation of periodic safety reports including, but not limited to the Addendum to clinical overviews (ACO). Conduct kick off meetings, authoring/lead preparation and submission of periodic safety reports (PSRs) including PBRERs and DSURs-Manage electronic Data Submission (eDS) activities, improving efficiency by 30%. To ensure the format and submission-readiness validation of all documents that need to be prepared in the official Sanofi electronic Document Management System (eDMS) such as clinical documents, CTD etc. Perform compilation/publishing of documents and implement navigation required to submit dossiers to Health Authorities-Write and/or edit under guidance high-quality safety documents, medical section of Periodic Benefit-Risk Evaluation Report, medical sections of Addendum to clinical overview, Disease and Product ID Cards, product alerts and trial transparency documents. Delivery of high-quality medical documents in time and in compliance with internal and external standards and guidelines-Coordinate product alerts management with faster response time and Drive regulatory compliance through timely submissions and quality standards-Lead multiple concurrent projects with global stakeholders and ensure cross-functional collaboration.

Education

• Sri Padmavati Mahila Visvavidyalayam

  Bachelor of Pharmacy - BPharm

• Gokaraju Rangaraju College Of Pharmacy

  Master's degree, Pharmaceutical analysis

  2019 — 2021