S
Shubham
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State of Berlin, Germany
Résumé
Jobs
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Senior Pharmacovigilance AssociateICON PlcMay 2022 - Current (4 years 1 month)• Experience in working with different client and led multiple studies (5 studies) as Study Lead and Backup Lead • Serve as a primary scientific point of contact for clinical safety team members, providing mentorship, project-specific guidance, and training on best safety practices. • Ensure timely reporting of ICSRs to local competent authorities in compliance with national pharmacovigilance (PV) reporting requirements, submission to investigators & ethics committee including PSURs, DSURs • Generation of quality and compliance report and proper execution ofaction related to KPIs, Matrix, QEs and CAPAs • Generate and present monthly reports to ensure accurate and up to-date safety data management • Implement pharmacovigilance processe- Pharmacovigilance SpecialistTata Consultancy ServicesSep 2017 - Sep 2019 (2 years 1 month)• Processed drug safety reports, including Quality check for accurate data entry into database • Coordinated patient cases by collecting and follow up with patient, scheduling calls in case of queries • Supported the creation of Individual Case Safety Reports (ICSRs) for adverse events arising from clinical trials, spontaneous reporting systems, and literature sources • Coordinated and developed a PV training, ensuring the completion of compliance-related training programs • Monitored the workflow for solicited cases to ensure expected volumes and accurate data captured • Liaised with clients to get clear understanding of Project needs like project improvement plans, Study timeline, weekly project updates, and quality meetings • Supp
- Drug Safety AssociateTata Consultancy ServicesJan 2016 - Aug 2017 (1 year 8 months)• Performed Case Receipt and triage and Central case Processing for TA like Oncology, Specialist Medicine, Consumer Health, Cardiovascular Medicine and Women Healthcare • Managed end-to-end case processing in Argus Database, from case receipt, data entry, and coding to case assessment, narrative writing, and submission in compliance with GVP and global regulatory standards • Proficient with Using Medical Dictionary (MedDRA), and following client's user manual, SOPs, and regulatory timelines to ensure accuracy and patient confidentiality • Acted as a Subject Matter Expert (SME) for Argus Database, providing training, troubleshooting, and process optimization to enhance workflow efficiency. • Collected, evaluated and followed up for pati
Education
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- IMBAInternational University ofApplied ScienceMar 2020 - Jan 2022 (1 year 11 months)
- CPost-Graduation DiplomaClinomics Institute of Clinical ResearchNov 2016 - Nov 2017 (1 year 1 month)
- Bachelor of ScienceUniversity of MumbaiApr 2012 - Jul 2015 (3 years 4 months)