Himesh Kendre
Assistant I PSS (SafetyScienceAnalyst) || SAS certified specialist
- Role
- Safety Science Analyst at Fortrea
- Location
- Pune, MH, IN
- LinkedIn followers
- 500 followers
Experience
Safety Science Analyst
Jul 2025 — Present · Pune, IN
Perform case intake and triage of safety reports from spontaneous sources and clinical trials.Assist in the processing of adverse events (AEs) across global safety databases.Conduct accurate data entry of safety information into adverse event tracking systems.Write clear and concise patient narratives and code adverse events using MedDRA (especially for marketed products).Support the preparation and submission of expedited and periodic safety reports (e.g, CIOMS, DSUR, PADER).Ensure timely distribution to regulatory authorities, ethics committees, clients, investigators, and internal project teams.Prioritize case processing to meet global regulatory and study-specific timelines.Maintain compliance with ICH-GCP, regulatory guidelines, and company SOPs.
Education
Shivlingeshwar college of pharmacy Almala
Doctor of Pharmacy - PharmD
2019 — 2025
Swami Ramanand Teerth Marathwada University
Doctor of Pharmacy - PharmD
2019 — 2025
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