Steven Godad
Senior Specialist. Pharmacovigilance System configuration at Organon- Claim this Profile
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Bio
Experience
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Organon
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Specialist. Pharmacovigilance System configuration
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Sep 2022 - Present
Handling regions of EMEA, LATAM, APAC for timely updating argus safety database as per requests from each local PV. conducting annual review of TR and CS Updating the reportability rules and reporting destination in Argus as per local PV request. Biannual MedDRa review. Adding and withdrawing product license in Argus safety databse. Setting up webtrader accounts for local PV as per their request Handling regions of EMEA, LATAM, APAC for timely updating argus safety database as per requests from each local PV. conducting annual review of TR and CS Updating the reportability rules and reporting destination in Argus as per local PV request. Biannual MedDRa review. Adding and withdrawing product license in Argus safety databse. Setting up webtrader accounts for local PV as per their request
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Tata Consultancy Services
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India
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IT Services and IT Consulting
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700 & Above Employee
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Business Process Lead
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Feb 2022 - Sep 2022
Handling LATAM, APAC, EMEA regions for updating GPV sytem Argus (Oracle) in order for timely submissions of Adverse event reports ICSR to HA, BP, EC etc. Generating daily reports to identify new licenses being added to the company product list and updating and configuring the same in Argus. Closely working with MR, CSRM, case processing team to update MedDRA updates in Argus on biannual basis. Looking after the ICH R3 requests by countries for submission of E2B reports in particular XML format. Closely coordinating with stakeholders to meet the timelines as per HA requirements. Setting up web trader accounts for countries as per their request. Show less
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Cognizant
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United States
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IT Services and IT Consulting
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700 & Above Employee
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Data Analyst
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Dec 2019 - Feb 2022
Traiging and booking of safety cases in Argus affiliate.Training of new associates in terms of process. Subject matter expert in Vigilance agreement partners reconciliation and VAP exchange. Traiging and booking of safety cases in Argus affiliate.Training of new associates in terms of process. Subject matter expert in Vigilance agreement partners reconciliation and VAP exchange.
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Teva Pharmaceuticals
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Israel
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Assurance Specialist
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Apr 2018 - Dec 2019
Handling product quality complaints and databasing the same in trackwise for US market and also interacting with stakeholders and sites for investigation on product quality issues, conducting follow ups with reporter Handling product quality complaints and databasing the same in trackwise for US market and also interacting with stakeholders and sites for investigation on product quality issues, conducting follow ups with reporter
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Education
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St. Johns institue of pharmacy
Bachelor's degree, Pharmacy