Farheen Taj
Regulatory Reporting Specialist | Pharmacovigilance & Medical Device Compliance | FDA, EMA, Health Canada Expert | MedDRA, Argus, TrackWise | Medical Writing & Adverse Event Reporting
- Role
- Regulatory Reporting Specialist at Akkodis
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Farheen Taj
Experienced Regulatory Affairs Professional with 6+ years in Pharmacovigilance and…
Experience
Regulatory Reporting Specialist
May 2024 — Present · US
Draft and submit MedWatch 3500A reports for Class medical devices like urology, interventional radiology, reproductive health and critical care to the US FDA, ensuring compliance with 21 CFR 820. Prepare and submit EU MDR reports per ISO 13485 and ISO 14971 standards.•Conduct initial evaluations of device complaints to determine reportability, ensuring compliance with regulatory standards. Performing 25-day sweeps to prevent correction reports and ensure timely compliance with global regulatory requirements.
Education
Rajiv Gandhi University of Health Sciences
Bachelor's of dental surgery, Dentistry
2017
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