Shrishail Dhayagonde
Drug safety associate
Mangalwedha,Maharashtra
Summary
To seek challenging job that provides exposure to new technology, to achieve professional growth along with organization that will help to enhance skills.
Overview
5
5
years of professional experience
4
4
years of post-secondary education
1
1
Certification
4
4
Languages
Work History
Drug Safety associate II
Parexel International India
01.2022 - Current
- ICSR case processing of solicited and spontaneous and non-interventional study cases in safety database ARISg
- To perform follow up activities to obtain case specific medical information
- To perform full data entry including event coding using MedDRA, product coding using WHO-DD and writing medically cohesive case narrative based on reported information as per client SOP
- To support compliance activities including late case investigation of ICSR to various health authorities and business partners to determine the cause of lateness.
Pharmacovigilance case processor
TATA Consultancy Services Ltd.
1 2017 - 7 2019
- Promptly and accurately identification, interpretation & extraction of adverse events and all corresponding case information from source document
- Tracking of all information extracted from source document into global PV safety database Argus
- Check of consistency of product technical complaint case in global complaint database with corresponding global PV safety database Argus
- Coding of adverse events into global PV safety database Argus using MedDRA
- Timely and accurate creation of quality safety assessment evaluating the potential impact of potential quality safety defect on reported adverse event in global complaint database and global PV safety database Argus
- Definition of appropriate MedDRA and WHO-DD coding corresponding to error codes for quality defect as described in global complaint database.
Senior Drug Safety Associate
Bioclinica
11.2021 - 04.2021
- ICSR case processing of solicited, non-interventional study cases and processing of product quality complaint cases of medical devices in safety database Argus
- To perform full data entry of ICSR including coding of events using MedDRA, coding of drug using WHO DD, writing of the narrative as per the SOP
- To perform follow-up activities
- To perform quality review of processed ICSR and provide feedbacks to case processor.
Pharmacovigilance case processor
Cognizant Technology solutions
08.2019 - 09.2020
- Triaging of safety cases in safety database Argus
- Bookin and case management activity in safety database Argus
- Perform data entry of all fields in safety database including event assessment
- Narrative writing/ i-narrative summarizing for all safety cases
- Processing of initial and follow up reports as per client process and procedure
- Generation of action items in safety database
- Perform safety case correction activities, deactivation and case rejection
- To perform event coding, product coding, labelling and preparation of narrative/I narrative and summarization of essential details of the case.
Education
B.Pharm -
Savitribai Phule Pune University
Pune 07.2012 - 06.2016
H.S.C - undefined
Maharashtra state Board, Pune
S.S.C - undefined
Maharashtra state Board, Pune
Skills
Team work
Adaptability
Quick learner
MS CIT
Power-point
Ms-excel
Ms-word
ICH GCP
GVP modules
Good knowledge of safety database Argus and ARISg
Personal Information
- Total Experience: 6 years in Pharmacovigilance field
- Date of Birth: 07/10/1993
- Gender: Male
- Nationality: Indian
- Marital Status: Married
Areas Of Interest
- Pharmacovigilance
- Medical Writing
- Clinical research
Projects
Completed the project work and review work on “Drug Solubility: Importance and Enhancement" in 3rd year B. Pharmacy.
Activities
- Participated In ''N.S.S'' camp in 3rd year B. Pharmacy at Sadatpur.
- Participated in several cultural event and seminar.
- Worked in Earn and Learn scheme in college.
- Participated in BLOOD DONATION CAMP in N.S.S. CAMP
Training
I have completed one-month implant training in Wockahardt Pharmaceutical Ltd, Aurangabad.
Disclaimer
I hereby declare that all the above-mentioned information is true to the best of my knowledge and believe.
Certification
MSPC registered pharmacist
Timeline
Drug Safety associate II
Parexel International India
01.2022 - Current
Senior Drug Safety Associate
Bioclinica
11.2021 - 04.2021
Pharmacovigilance case processor
Cognizant Technology solutions
08.2019 - 09.2020
MSPC registered pharmacist
10-2016
B.Pharm -
Savitribai Phule Pune University
07.2012 - 06.2016
Pharmacovigilance case processor
TATA Consultancy Services Ltd.
1 2017 - 7 2019
H.S.C - undefined
Maharashtra state Board, Pune
S.S.C - undefined
Maharashtra state Board, Pune