Gauri Bihade
Safety Science Coordinator I at Fortrea | Pharmacovigilance & Drug Safety Professional | ICSR Lifecycle Management | MedDRA Coding | Argus Safety | Aggregate Safety Reporting (PBRER/PSUR/DSUR) | Regulatory Compliance
- Role
- Safety Science Coordinator i at Fortrea
- Location
- Pune Division, MH, IN
- LinkedIn followers
- 500 followers
About Gauri Bihade
Pharmacovigilance professional with over 4 years of hands-on experience in end-to-end ICSR lifecycle management for global pharmaceutical products. Proficient in case processing, medical coding (MedDRA), narrative writing, follow-ups, and quality review within Argus Safety database. Strong understanding of ICH guidelines and global regulatory requirements (FDA, EMA), ensuring compliance with reporting timelines and data integrity standards. Experienced in supporting aggregate reporting activities including data reconciliation, line listings, and periodic safety reports (PBRER/PSUR/DSUR). Recognized for accuracy, efficiency, and commitment to regulatory excellence.
Experience
Safety Science Coordinator i
Aug 2023 — Present · Pune, IN
Education
Savitribai Phule Pune University
Bachelor of Pharmacy - BPharm, Pharmacy
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