Name of Employee

Vidisha Patil

Summary

-Overall 9 years of ongoing experience in Clinical Research (Pharmacovigilance + Clinical Data Management) since Nov-2009.

Education

-Advanced Certificated Course in Clinical Research (ACCCR) from CHM College, Ulhasnagar. Thane district. Mumbai : March-2009.

-Msc. In Zoology (Endocrinology) from Khalsa college, Mumbai University: April-2008.

-Bsc. from Birla College, Mumbai University: April-2006.

-Higher secondary school (10+2) from Hindi Junior college. Kalyan (W), Thane district, Maharashtra: March : 2003

-Secondary school (class 10) from Gurunank English High School, Kalyan (W), Thane district, Maharashtra: March : 2001

Training and Certifications

- Advanced Certificated Course in Clinical Research (March 2009)

Publications, Seminars & Presentations-

-Clinical Trials & Stem cells (year 2009)

-Prostaglandins (year 2008)

-GMO & their foods (Genetically Modified Organism) (year 2007)

Professional Affiliations-

NA

Professional & Teaching Activities

NA

Work Experiences:-

02-Dec-2013– Till Date Safety Data Analyst, Sciformix, Mumbai

- Execute drug safety data management processes – a combination of case intake, triage, case entry, medical coding, narrative writing, case follow-up with accountability for quality and timeliness of deliverables and responsibility for process improvements.

- Implement consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.

- Assessing the legal cases.

- Ensure compliance of operations with governing regulatory requirements.

- Create, maintain and assume accountability for a culture of high customer service.

Oct- 2010 to Sep-2013 Data Analyst, Clinical Data Management, Cognizant. Mumbai.

- Dealing with the trial site and investigator directly and indirectly with subjects (patient). Worked on OC-RDC & OC classic tools.

- Handled two studies successfully as a POC. Coordinator of other three studies also (cardiovascular unit). e-CRF data completion and Query resolution.

- Ensuring the Data integrity and security as per GCP.

- Perform all data management activities (Data review, Queries, Deviations and Medications in adherence to Protocol)

- Reporting and communicating with the study clients via phone call bi-weekly to discuss study related issues.

Nov- 2009 to Oct-2010 Data Process Executive, Pharmacovigilance, Cognizant. Mumbai.

- Tracking all adverse events reports received and completed.

- Assessing all source documents and compile data in an adverse event report (AEM form)

- Doing Peer review for the data entered.

- Worked on ARGUS tool, duplicate case search, Book-in the case, work log tracker handling, data processing.

Contact this candidate