Shrishail Dhayagonde
Drug Safety Associate
Solapur,MH
Summary
Pharmacovigilance professional (Drug safety associate) holding total experience of 7 years in activities like triage, end to end case processing, quality review, follow up activity, root cause analysis, mentoring of new joiner, training new joiners on information security regulations. Worked on oncology, gynecology, neurology products and drugs used for infectious disease treatment. Worked 4 years on Argus and more that 3 years on Arisg safety database.
Overview
2025
2025
years of professional experience
1
1
Certification
Work History
Drug Safety Associate II
Parexel International India
Hyderabad, Telangana
01.2022 - 01.2025
- To handle ICSR case processing of solicited, 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, labelling assessment 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 cause of lateness.
Senior Drug Safety Associate
Bioclinica
Mysore , Karnataka
11.2020 - 05.2021
- 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 narrative as per SOP
- To perform follow-up activities
- To perform quality review of processed ICSR and provide feedback to case processor.
- Worked on drug safety cases of world's first COVID vaccine.
Pharmacovigilance case processor
Cognizant Technology solutions
Mumbai , Maharashtra
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.
Pharmacovigilance case processor
TATA Consultancy Services Ltd.
Mumbai , Maharashtra
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.
Education
B.Pharm - Pharmacy
Savitribai Phule Pune University
07-2016
H.S.C -
Maharashtra State Board, Pune
07-2011
S.S.C -
Maharashtra State Board, Pune
07-2009
Skills
- 4 Years experience of Argus and 3 years experience of ARISg
- Adaptability
- Adapted rapidly to new responsibilities
- MS CIT
- Power-point
- Ms-excel
- Ms-word
- Ensured adherence to ICH GCP guidelines
- GVP modules
Languages
English
Hindi
Marathi
Kannada
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
Contact
Mangalwedha, Solapur 413319
Education
Ahemadnagar,VMHS SALAGAR BK,VMHS SALAGAR BK,Pune
Certifications
10-2016
Areas Of Interest
- Pharmacovigilance
- Medical Writing
- Clinical research
Personal Information
- Total Experience: 7 years in Pharmacovigilance field
- Date of Birth: 07/10/1993
- Gender: Male
- Nationality: Indian
- Marital Status: Married
- Title: Drug safety associate
Timeline
Drug Safety Associate II
Parexel International India
01.2022 - 01.2025
Senior Drug Safety Associate
Bioclinica
11.2020 - 05.2021
Pharmacovigilance case processor
Cognizant Technology solutions
08.2019 - 09.2020
B.Pharm - Pharmacy
Savitribai Phule Pune University
H.S.C -
Maharashtra State Board, Pune
S.S.C -
Maharashtra State Board, Pune
Pharmacovigilance case processor
TATA Consultancy Services Ltd.
1 2017 - 7 2019
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