Safety Clinical Research

Curriculum Vitae

Name : Vinoth Vijay. V

DOB &Age : 17th September 1984 &26

Address : # */***, **** *****, ***********, Vellore-632006.

Designation : Clinical Research Coordinator& Safety Reviewer.

Present Employer Address : Department of Oncology, ChristianMedicalCollege, Vellore.

Career Objective : To pursue a career in the field of Pharmacovigilance& Drug Safety.

Email ID : ************@*****.***

Mobile No. : 978-***-****

Passport No. : G6603200

Place of Issue : Chennai

Professional Qualification:

Degree College / University Major Subjects Grade Years

B. Pharmacy SRM College of Pharmacy.

(Dr. M.G.R Medical University) Pharmaceutical Sciences, Pharmacology, Pharmacognosy, Medicinal Chemistry, Clinical Pharmacy, Pharmacy Practice First Class 2002 – 2006

PDCR Catalyst Clinical Services GCP, Regulatory affairs, Clinical Research. First Class 2008

MBA Hospital Management

Alagappa University Hospital Management Principles Hospital Support Services, Planning & Designing, Hospital Laws, Medical Records, Quality Management, Counseling.

To be obtained 2010 - 2011

Experience : More than 4 Years as CRC& Safety Reviewer at Christian Medical College (since 2007)6 Months experience as Claims Analyst in Perot systems (Dec 2006 to Jun 2007)

Area of Interest :Pharmacovigilance, Clinical Research & Hospital Administration.

Job Description in the capacity of employment:

• Reviewing and summarizing the safety reports of the patients.

• Assessing the safety reports of its category.

• Evaluation of the safety repots based on the individual cases.

• Assessment of safety reports including the determination of seriousness, expectedness and causality of adverse events.

• Providing the drug safety support for the patients.

• Tracking and distribution of the adverse events.

• Over all in charge of day to day activities of the assigned clinical trials.

• Documentation of all project related adverse events.

• Submitting safety reports of the patients from different sites to the Ethics committee.

• Typing and editing the case reports.

• Submitting safety reports database in a prescribed format.

• Reporting the serious adverse events of the site within the time frame to the sponsor as well as the ethics in their prescribed format.

• Entering the data and the safety information of the patients in the eCRF.

• Good Knowledge about ICH-GCP guidelines.

• Ensure compliance of SOPs.

• Perform activities/tasks as communicated by the principal investigators.

• Determination of patient eligibility.

• Performing study drug accountability.

• Completing Case Report Forms (eCRF& Hard copy).

• Mixing of chemotherapy drugs & dose calculation.

Clinical Trials Details:

S. No Trial Phase Region No. of Trials

1 Phase I (BA& BE) Glioblastoma& Breast 4

2 Phase II Glioblastoma, Nasopharynx,Breast& Cervix 4

3 Phase III Head & Neck, Sarcoma & NSCLC 5

Workshop Attended: FogartyInternational Center/NIH/The South Asian Cochrane Network Workshop on Ethics in Research and Good Clinical Practice (GCP).

UG Project :Formulation & Evaluation of sustained release Diclofenac Tablets by Microencapsulation Method. Project was done in the Laboratory for about 6 months.

Result : Excellent

Major Achievements : Working as Clinical Research Co-ordinator in more than 10Multicentre Trials. (International Phase I, II and III) & a well experience in Safety Reports profile from various studies (Phase I to Phase III).

Computer skills : Microsoft Word, Microsoft Excel, Power point, participated in Trial startup meetings.

Contact this candidate