Dr. Ashish Chougule
Pune
Summary
Drug Safety Physician with more than 7 years of experience in Pharmacovigilance. Expertise in ICSR Review/ Literature review/CTPS. Experience in achieving quality results and cross-team collaboration. Proactive and excited to partner with like-minded individuals to achieve goals.
Overview
9
9
years of professional experience
Work History
Senior Drug Safety Physician
Parexel
Pune
03.2024 - Current
- Performing medical review of cases not limited to (including non-serious and serious spontaneous (including legal cases), clinical trial, and literature cases including combination products {drug-device}) according to Client/Parexel SOP.
- Assessing seriousness, listedness / expectedness of reported events.
- Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality.
Lead Medical Reviewer
Cognizant Technology Solutions
Pune
11.2021 - 03.2024
- Monitor & manage team weekly & monthly productivity metrics, team attendance, daily workflow allocations.
- Review solicited, spontaneous ICSR, SUSAR's. Daily target 35- 40 cases/day. Provide company causality per ICH GCP/ GVP/ client guidelines.
- Provide clinical & process guidance to new medics and case processors for seamless & error free case processing.
- Successful migration from Aris G to Veeva vault safety database, being a part of the test team reporting glitches to the software engineers.
Senior Clinical Safety Reviewer - CTPS
Cognizant Technology Solutions
Pune
02.2020 - 10.2021
- Clinical trial patient safety- Manage a 10 year post marketing observational study for pediatric crohn's disease. Run daily serious & non serious reports per the Investigative brochure, Risk management plan.
- Review information per report, connect and query with all the sites worldwide for any discrepancies in patient data.
- Provide company causality for the adverse event.
- Manage safety mailbox. Receive & report safety signals from the investigator and report it to the sponsor.
Senior Medical Reviewer - ICSR
Cognizant Technology Solutions
Pune
02.2018 - 01.2020
- Perform solicited & unsolicited ICSR review. Daily target of 30 – 35 cases / day
- Provide company causality per client guidelines.
Senior Safety Scientist-Literature review
Tata Consultancy Services
Pune
06.2016 - 02.2018
- Reviewing the published reports/ biomedical literature for ICSR’s related to company drugs with a daily target for 25 -30 articles per day.
- Apply regulatory and internal company guidance to determine case safety reports.
- Search and report new signals reported in the literature per drug label.
- Awarded best performer on 24/May/2017.
- Internal promotion to team trainer- Provide training and guidance to the new recruits on the project SOP's/ process of literature review/ impart thorough training of the database
Resident Medical Officer-ICU
Jeevan Anmol Hospital
New Delhi
01.2015 - 12.2015
- Management of Critical cases like cardiac arrest, respiratory arrest, post partum haemorrhage, etc.
- Adult ventilatory management & CPR.
- Discussion of management with consultant surgeons, physicians.
- Ensuring continuous medical cover for all patients admitted to the Intensive Care Unit
Education
M.D. - Medicine
Davao Medical School Foundation
Davao City, Philippines2012
Skills
- Expertise in Argus, Aris G, Veeva Vault, RAVE, Inform
- Medical review according to Client/ GVP guidelines
- Working knowledge of MedDRA and WHO DD
- Microsoft Office Suite expertise
Timeline
Senior Drug Safety Physician
Parexel
03.2024 - Current
Lead Medical Reviewer
Cognizant Technology Solutions
11.2021 - 03.2024
Senior Clinical Safety Reviewer - CTPS
Cognizant Technology Solutions
02.2020 - 10.2021
Senior Medical Reviewer - ICSR
Cognizant Technology Solutions
02.2018 - 01.2020
Senior Safety Scientist-Literature review
Tata Consultancy Services
06.2016 - 02.2018
Resident Medical Officer-ICU
Jeevan Anmol Hospital
01.2015 - 12.2015
M.D. - Medicine
Davao Medical School Foundation
Similar Profiles
Sruthi ReddySruthi Reddy
Clinical Data Manager at ParexelClinical Data Manager at Parexel
Yorde ONNEYorde ONNE
Highly Skilled Senior Clinical Research Associate at ParexelHighly Skilled Senior Clinical Research Associate at Parexel
Aneesah HudaAneesah Huda
Drug Safety Physician at ParexelDrug Safety Physician at Parexel