Irfan Shaik
Global Safety & Pharmacovigilance | Generative AI | Regulatory Intelligence | Business Intelligence | Clinical Trials
- Role
- Safety Specialist at Ora
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Irfan Shaik
Clinical Safety Specialist with 5.5+ years of experience in DSMB support, risk…
Experience
Safety Specialist
Jun 2025 — Present · Hyderabad, IN
Create and maintains Safety Management Plans (SMPs) and Medical Monitoring Plans (MMPs) for ongoing studies.• Performs quality checks on clinical safety database.• Tracks SAEs through completion and assists the Safety Physician/Medical Monitor to issue safety queries.• Reviews Safety Narratives for Medical Monitor input needed.• Assist with SAE/AESI/UADE/Pregnancy Report reconciliation with Data Management and Safety Vendor.• Prepares Patient Profiles on assigned studies for review during Clinical Data Review Meetings or for Data Safety Monitoring Board meetings.• Performs literature search to support aggregate reporting or expedited reporting.• Performs an analysis of similar events (AOSE) in the safety database.• Provide safety review of other clinical study documents as assigned by the Medical Safety Director.• Maintains Safety and Medical Monitoring Plans in the respective Project Trial Master File.• Serves as Safety Database superuser.
Education
Rajiv Gandhi University of Health Sciences
Doctor of Pharmacy - PharmD
2014 — 2020
Cliniminds Institute Of Health and Management
Advance PG Diploma in Clinical Research and Pharmacovigilance
2019 — 2020
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