Narendra Sonawane
M. Pharmacy (Pharmacology)
Jalgaon
Summary
Highly organized and detail-oriented professional with experience of 5.8 years in processing ICSR cases. Skilled in efficiently managing large volumes of data and ensuring compliance with regulatory guidelines. Seeking a challenging position where my expertise and dedication to quality will contribute to the success of the organization.
Overview
6
6
years of professional experience
3
3
Languages
Work History
Safety Data Analyst
Covance Scientific Services & Solutions Pvt. Ltd/ Labcorp drug development
2021.04 - 2023.04
Junior Safety Data Analyst
Sciformix Technologies Solutions Pvt. Ltd
2017.07 - 2021.04
- Implement consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures
- Ensure compliance of operations with governing regulatory requirements
- Create, maintain, and assume accountability for a culture of high customer services
- Execute drug safety data management processes - a combination of case entry, medical coding, narrative writing, peer review, case follow-up, report preparation
- Implemented consistent, efficient and quality processes to meet timeliness and deliverables according to requirements and standard operating procedures
Education
Post-Graduation -
AISSMS College of Pharmacy, University of Pune
Graduation - undefined
R.C.Patel College Of Pharmacy Shirpur, North Maharashtra University
H.S.C. - undefined
Nutan Maratha college, Maharashtra Board
S.S.C. - undefined
L.N.S. Highshool, Maharashtra Board
Skills
Microsoft excel
Microsoft PowerPoint
Microsoft word
Well-versed with Argus safety database
Strong computer skills including, creation of templates, presentations and working with safety databases applications
Sense of urgency and commitment for timely completion of activities
Ability to work independently, under pressure, demonstrating initiative and flexibility through effective innovative leadership ability
Strong technical and problem solving skills
Self-motivation and proactive stance to work
Areas Of Interest
Medical writing
Roles And Responsibilities
- Performing duplicate search, booking the case into Client’s corporate safety database, e.g. Argus,
attaching the Source Document form to the case, and then routing the case appropriately either for
primary review, data entry or invalid state. - Retrieving the cases by generating the appropriate work list.
- Narrative writing
- Coding of suspect products using ICDS and concomitant products using WHO dictionaries.
- Coding of events, medical history, and laboratory test using MedDRA dictionaries.
- Knowledge of WHO/MedDRA dictionaries.
- Ensuring events in all types of cases coded appropriately.
- Keeping the work log updated and completing the requisite trackers.
- Determine and perform appropriate case follow-up, generating and requesting follow-up letters.
- Client interaction for requirement gathering and various issues.
Personal Information
- Date of Birth: 04/01/1989
- Gender: Male
- Nationality: Indian
- Marital Status: Married
- Physically handicapped (left arm affected, ~20wpm typing speed)
Disclaimer
I hereby declare that the information furnished above is true and correct to the best of my knowledge.
Timeline
Safety Data Analyst
Covance Scientific Services & Solutions Pvt. Ltd/ Labcorp drug development
2021.04 - 2023.04
Junior Safety Data Analyst
Sciformix Technologies Solutions Pvt. Ltd
2017.07 - 2021.04
Post-Graduation -
AISSMS College of Pharmacy, University of Pune
Graduation - undefined
R.C.Patel College Of Pharmacy Shirpur, North Maharashtra University
H.S.C. - undefined
Nutan Maratha college, Maharashtra Board
S.S.C. - undefined
L.N.S. Highshool, Maharashtra Board