Faruk Ahamad
Associate (Complaint Vigilance Reporting) @Wipro
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WORK HISTORY
Associate (Complaint Vigilance Reporting) @Wipro
Kolkata, IN
Responsible for collecting, assessing, reporting, and identifying trends in incidents following the use of Pharmaceutical Products & Medical devices.Associated with complaint evaluation and investigation according to Standard Operating Procedure (SOP)Assessment of Complaints (events) for proposed MDR reportability and submit assessments to clients or regulatory authorities.Reportability assessment & Risk level assessment.
EDUCATION
Beldanga Srish Chandra Vidyapith
Intermediate
Jawaharlal Nehru Technological University Hyderabad (JNTUH)
Bachelor of Pharmacy - BPharm
ABOUT FARUK AHAMAD
I completed my B.pharmacy from Jawaharlal Nehru Technological University Hyderabad. I had working experience at pharmaceutical industry in the Analytical R&D department (oncology).Now working in IT health care services as a Safety Associate.I am passionate about patient safety and also I am well versed with:Pharmacovigilance concepts (MedDRA coding and WHO-Drug Dictionary coding) and Reporting guidelines (FDA, ICH, EMEA, and other international guidelines).Materiovigilance concepts (Detecting signals and analysing potential adverse events associated with medical devices and in vitro diagnostics (IVDS). Assessment of complaints (events) for proposed MDR reportability and submission of assessments to clients or regulatory authorities.Understanding of Drug Development Process including Drug safety and different Phases of Clinical Trials (Phase 0 to Phase 4)Knowledge of GCP and ICH guidelines including basic understanding of regulatory requirements for clinical research.Periodic Safety Update reports (PSURS), Periodic Benefit Risk Evaluation Reports (PBRERS) and knowledge of writing the Benefit Risk Evaluation (BRE).I am constantly seeking opportunities to expand my knowledge and stay updated with the latest developments in the field.
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