Arazu Sayed has an M.Sc in Clinical Research and Regulatory Affairs from SMU and a B.Sc in zoology from Mumbai University. She has over 8 years of experience in clinical research documentation and regulatory submissions for FDA and DCGI. Her previous roles include Documentation Officer at SIRO Clinpharm and tutor at Oxford Tutorials. She is affiliated with the Institute of Clinical Research and has received appreciation for her documentation skills.
Copyright:
Attribution Non-Commercial (BY-NC)
Available Formats
Download as RTF, PDF, TXT or read online from Scribd
Arazu Sayed has an M.Sc in Clinical Research and Regulatory Affairs from SMU and a B.Sc in zoology from Mumbai University. She has over 8 years of experience in clinical research documentation and regulatory submissions for FDA and DCGI. Her previous roles include Documentation Officer at SIRO Clinpharm and tutor at Oxford Tutorials. She is affiliated with the Institute of Clinical Research and has received appreciation for her documentation skills.
Arazu Sayed has an M.Sc in Clinical Research and Regulatory Affairs from SMU and a B.Sc in zoology from Mumbai University. She has over 8 years of experience in clinical research documentation and regulatory submissions for FDA and DCGI. Her previous roles include Documentation Officer at SIRO Clinpharm and tutor at Oxford Tutorials. She is affiliated with the Institute of Clinical Research and has received appreciation for her documentation skills.
Copyright:
Attribution Non-Commercial (BY-NC)
Available Formats
Download as RTF, PDF, TXT or read online from Scribd
Arazu Sayed has an M.Sc in Clinical Research and Regulatory Affairs from SMU and a B.Sc in zoology from Mumbai University. She has over 8 years of experience in clinical research documentation and regulatory submissions for FDA and DCGI. Her previous roles include Documentation Officer at SIRO Clinpharm and tutor at Oxford Tutorials. She is affiliated with the Institute of Clinical Research and has received appreciation for her documentation skills.
Copyright:
Attribution Non-Commercial (BY-NC)
Available Formats
Download as RTF, PDF, TXT or read online from Scribd
1 M.Sc in Clinical Research and Regulatory Affairs from SMU-Distance
education. 2 B.Sc in zoology (2006-2007) First class 63.75% aggregate from Mumbai University. 3 H.S.C science. (2003-2004).58.67% aggregate from Mumbai University. 4 S.S.C (2001-2002). From Symbiosis convent high school. 64.53% aggregate.
M.Sc PROJECT:
5 Clinical Trial Protocol preparation.
6 Submission of FDA forms for new drug application (NDA) 7 Presentation on Essential documents in Clinical Research
PRIVIOUS EXPERIENCE
Apr 2008 to Sep 2009:As Documentation Officer in SIRO Clinpharm Pvt Ltd. (Thane)
8 Oncology trial in phase II US FDA submission.
9 Diabetes type II trial in phase III FDA submission. 10 Diabetes trial in phase III DCGI submission
Key functions: •Maintain Clinical Trial Master Files. •Attend study meeting and prepare minutes of the meeting. •Coordinate & track non-drug clinical trials supply management (clinical trial supplies other than Investigational Product). •Update Site Regulatory Package checklist. •Prepare Regulatory dossiers for approval of trials and registration of pharmaceutical products •Coordinate with translator. •Maintain finance record. •EC submission. •Audit preparation. •Maintain & update study trackers.
Extra corporate activity in SIRO:
11 Review of Urdu ICF for all projects.
As tutor in Oxford Tutorials (Mumbra) from Jun 2007 to March 2008
Key Responsibilities:
12 Take lecture for H.Sc (Biology)
13 Conduct practicals 14 Attend parents-staff meeting 15 Organize seminars
TRAINING Jul 08 Workshop on Time Management, By Adecco Learning, Mumbai, India
May 08 Fundamentals of GCP and Role of quality in Clinical Research, By
Academy of Clinical Excellence (ACE), Kalina, Mumbai, India
AFFILIATION Affiliated to Institute of Clinical Research (ICR-U.K) since Jan 2008.
ACHIVEMENTS:
16 Appreciation from sponsor in Audit for good documentation and
presentation (June 2008-SIRO Clinpharm Pvt.Ltd).
Stood first in debate competition in intra-college competition (2006-Sandesh
College).
17 Passed elementary Drawing exam (2000-Govt of Maharashtra).
PERSONAL SKILLS: Comprehensive problem solving abilities, excellent verbal and written communication skills, ability to deal with people diplomatically, willingness to learn, team facilitator & hard worker.
EXTRA CURRICULAR: Basic in Dos, Windows & M.S office (2002-Noble Computer academy). PERSONAL PROFILE:
Father’s Name : S. Ali Mohammed zaidi.
Nationality : Indian
Date of Birth : 15th July 1986.
Sex : Female
Hobbies : Playing volley ball, Writing poems, Reading books.
Marital status : Married
Languages Known : English, Hindi, Urdu and Marathi.
