Professional Experience Data Entry

Kanishka Sharma

***, *** *****, ******** **********, SFS Flats, C&D Block, Shalimar Bagh, Delhi 110088 +91-882*******, 011-******** ****************@*****.*********:****************@*****.***

Objective

●To integrate my skills, knowledge and abilities to take up the challenges and opportunities in the area of Pharmacovigilance.

●To be associate with an organization that rewards performance and provides a conductive environment for growth and professional development.

Academic Qualification

Intermediate 2003-2004

B. M. Gange Girls Sr. Sec. School, Delhi

CBSE Board

High school 2001-2002

Canterbury Public Sec. School, Delhi

CBSE Board

Professional Qualification

Masters in Business Administration (HR) Result awaited IGNOU, Delhi

Bachelor of Pharmacy 2004-2008

Lloyd Institute of Management & Technology,

Greater Noida. U.P. Technical University.

Professional Experience

Working as Senior Pharmacovigilance Associate (SPA)

APCER Life Sciences, Delhi Feb 2016 – Till Date

Job Profile:

● Data Entry of ICSRs in Pharmacovigilance database.

●Entering source data in the database, Coding, Narrative(s) writing and Generate Follow-up letters.

● Review of literature articles and assessment for identifying valid ICSRs

●Support in Signal detection of the ADRs with cases received from client's products

●Quality Check of ICSRs in database

● Compliance to project guidelines

● Execution of Company Standard Operating Procedures

●Builds and maintains good relationships across functional units and company affiliates

●Maintain awareness of changes to/new regulations affecting PVG activities

●To carry out necessary administrative duties required for the job

●Other duties as assigned by management

Worked as Senior Pharmacovigilance Officer (HCP),

Wipro Healthcare & Life Sciences, Delhi

Apr 2011- Feb 2016

Job Profile:

●Perform coding of drugs using CDD/WHO Dictionary.

●Perform coding of adverse events, lab tests, indications, etc. by using the MedDRA drug dictionary.

●Ensure correct ranking/sequencing of adverse events and drugs.

●Classification of cases - e.g. At risk, medical confirmation.

●Establish the validity and seriousness of a case.

●Generate appropriate action items/letters with proper date and timelines.

●Complete the respective contact log with the required details.

●Coordinate with different functional team members, e.g. team leaders, clinical data verifiers, other health care professionals and QC’S for completion of various cases with accurate consistency and proper validation.

●Processing and reporting ICSRs originating from- Spontaneous reports, Non-interventional (solicited) reports and Clinical trial reports in Global safety database ARGUS.

●Patient narrative- Write, Transcription edit, consistency matching as per Regulatory guidelines.

●Duplicate case search, E2B Linking and Cross reference of reports.

●Reply or feedback on issues addressed while case processing to Client via mail or vice-versa.

●Proficient in case processing of Device cases, exposure in utero/ pregnancy reports, breastfeeding case, Product complaint cases, Lack of efficacy cases, Invalid cases, literature cases and Follow up cases.

●Checking E2B Validation for ICSRs for successful submission of the reports.

●Providing training regarding drug safety reporting to new joiners and maintaining documentation of such training.

Worked as Store Assistant at State T.B. Office. Jan 2011 – Apr 2011

Worked as Office Assistant at Piramal Health Care. Oct 2008 – Jan 2011

(Now Abbott Pharmaceuticals)

Personal Strengths and Training

●Proven flexibility and adaptability, Strong analytical and planning skills

●Ability to work in a team environment and independently as needed

●Organizational skills - prioritizing and responses to constantly changing situations

●Coordinate and manage administrative project issues

Industrial Visit

●Cyper Pharma, Baddi (H.P)

●Ind Swift, Baddi (H.P)

●Glyco labs, Baddi (H.P)

Summer Training

●Summer training in DABUR INDIA LIMITED

Personal Details

Father’s Name : Mr. Nagendra Sharma

Mother’s Name : Mrs. Sushila Sharma

Date of Birth : 1st Aug 1987

Marital Status : Unmarried

Gender : Female

Language Known : Hindi & English

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