Clinical Research Data
Resume:
Resume
Name: Burhanuddin Sunely
Nationality: Indian
Contact:
A- 14, Hooseini Building, MG road, Kandivali(W), Mumbai-400067.
- ******************@*****.***
Career objective
To work with a leading company and use my knowledge to the best of my ability combined with perseverance, so as to contribute towards the goal and apparently towards the growth of the company.
Education profile
1)B. Pharma Year: 2016-20
Board: Savitribai Phule Pune University
Institute: Sinhgad institute of pharmaceutical sciences(lonavala)
CGPA: 6.9
2)H.S.C Year: 2015-16
Board: Maharashtra board
Institute: Shri T.P Bhatia Jr. college of science
Percentage: 70%
3) S.S.C Year: 2013-14
Board: Maharashtra board
School: St. Anne’s High School
Percentage: 80.81%
Professional skills:
Advance Program in Clinical Research and Management (APCRM) from CLINI INDIA.
Clinical Trial Management
• Phases in Clinical Trials, ICH-GCP, Schedule Y, Clinical Trial Stakeholders
• Site selection and visits, Monitoring (SDV), Audits & Inspections
• IND and NDA, DSMB, IEC and IRB, CRF, Protocol, Investigational Brochure
• Regulatory Guidelines etc.
Clinical Data Management
• Basic Knowledge of Clinical Data Management
• CDISC, CRF Design, EDC, CDMS, SDTM Mapping
• Data Entry, Database Closure, Laboratory Data, Protocol Data, Query Data and
• Safety Data Management, SAE Reconciliation, Discrepancy Management
• QA and QC of Clinical Data Management, SOPs and Audit etc.
Pharmacovigilance
• Introduction and Basics of Pharmacovigilance
• Pharmacovigilance Regulations
• ADR and AE, ADR and AE Reporting System, Case Safety Report, Case Processing
• MedDRA Coding, AERS, ARGUS, Safety Database
• Narrative Writing
Medical Writing
• Basics of Clinical Trial Protocol Writing, ICF Preparation, CSR Writing
• Regulatory Affairs, Regulatory affairs, writing and submission
• Common Technical Documents (CTD)
• Basics of Safety Writing
Regulatory Affairs
• Overview of regulatory affairs
• Drug development process
• Information of Common Technical Documents (CTD)
• Schedule Y
Internship:
INFLUX HEALTHCARE JUNE 2019- JULY 2019
Successfully completed one-month internship at Influx Healthcare Pvt.Ltd. (Palghar, Mumbai) from 10th June 2019 to 9th July 2019.
Tools and Skills
Office tools: MS word, excel, power point and outlook.
Operating system: Windows XP, Windows 7,9,10
Academic achievements/ Extra curricular activities
Member of Saifee Ambulance (St John Ambulance Brigade).
Volunteered as first aider as a part of Saifee Ambulance in many festivals such as Ganesh Chaturthi, Ramadan, Muharram and Dhai handi.
Former band member of Saifee ambulance.
Organized blood donation camp in my locality as a part of Saifee Ambulance.
Played football for college team (Sinhgad institute).
Runner up in inter hostel tennis competition (Sinhgad campus lonavala).
Participated in skit competition on annual festival- Sunhare Lamhe of college
Actively participated as a delegate at SPPU sponsored two days national seminar.
Areas of interest
Clinical Data Management
Regulatory affairs
Clinical research
Quality control and Quality assurance
Strengths
Positive Attitude
Sincere and Hard Working
Punctuality and Dedication.
Adaptable in any environment etc.
Strong memory.
Languages Known:
English
Hindi
Marathi
Gujarati
Hobbies:
oTravelling
oTrekking
oReading (novels, newspapers)
Declaration:
I confirm that, the above information is true and correct to the best of my knowledge.
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