To leverage my expertise in pharmacovigilance, drug safety and clinical research to contribute to the success of an organization.
Overview
11
11
years of professional experience
Work History
Data Analyst
Cognizant Technology Solutions
Navi Mumbai
11.2013 - Current
Education
M. Pharm in pharmaceutics -
Pune University
01.2013
B. Pharm -
Mumbai University
01.2011
H.S.C -
R.K. Talreja College, Ulhasnagar
01.2007
Skills
Comprehensive knowledge of international drug safety and pharmacovigilance principles and regulations
Good understanding of the quality and confidentiality of patient data and process involved in processing the data to make it presentable as per regulatory requirements
Excellent interpersonal communication, organizational and leadership skills
Good knowledge and understanding of the standard operating procedures and abiding by the guidelines
Proficient in Microsoft Word, Excel and Powerpoint presentations
Self learning desires with sincerity and hardworking nature
Job Profile
Part of a global team working towards monitoring and reporting adverse drug effects, understanding regulatory requirements and maintaining safety databases. Working knowledge of different safety database system (e.g., ARGUS, ARIS-g, AWARE and VEEVA vault). Performing case initiation, data entry and quality review of individual case safety reports including spontaneous cases, clinical trial cases, literature cases prior to reporting to the regulatory following the SOPs and timelines. Involved in processing of clinical trial cases as per the protocol guidelines, reconciling information with RAVE database and performing study blind break as per the study requirements. Knowledge of conduct of clinical trials including clinical trial application, pediatric study requirements, clinical labelling, end of clinical trial notifications and information brochure. Mentoring new associates, providing supervision and teaching key skills in Drug Safety.
Career Overview
Cognizant Technology Solutions, Trainee Junior Data Analyst, Data Analyst, Pharmacovigilance, 11/25/13 to Present
Sr. Executive Support at Cognizant technology Solutions, Cognizant Technology SolutionsSr. Executive Support at Cognizant technology Solutions, Cognizant Technology Solutions