Sheabaaz Ahmed
Pharmacovigilance Analyst | Aggregate Safety Report Writer |PBRER Report| Regulatory Compliance
- Role
- Aggregate Report Writer at Sitero
- Location
- Kurnool, AP, IN
- LinkedIn followers
- 500 followers
About Sheabaaz Ahmed
I am a dedicated and highly detail-oriented pharmacovigilance professional with strong…
Experience
Aggregate Report Writer
Jul 2024 — Present · Mysore, IN
Key Responsibilities & Achievements: • Authored and reviewed a wide range of aggregate safety reports, including PBRERs, PADERs or and Addendum to Clinical Overviews, in accordance with ICH E2E, GVP Modules, and country-specific guidelines (EMA, FDA, MHRA, etc.) • Interpreted and integrated safety data from multiple sources (clinical trials, spontaneous reports, literature, PSURs) into comprehensive regulatory documents • Collaborated closely with cross-functional teams, including Safety Physicians, Regulatory Affairs, Clinical Teams, and Biostatistics, to ensure scientific accuracy, regulatory compliance, and timely submissions • Contributed to trend analysis through data review and interpretation • Maintained document consistency, quality control, and audit readiness through robust QC processes and adherence to internal SOPs • Worked with industry-standard safety databases and tools such as ARISg and MedDRA
Education
Santhiram College of Pharmacy, Nandyal
Doctor of Pharmacy - PharmD
2017 — 2023
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