Harsh Jain
PharmaCovigilance Techno-Functional Consultant
Ghaziabad
Summary
Quality-focused Principal Consultant successful at managing customer expectations and delivering exceptional results built on extensive industry knowledge and abilities.
Effective advisor communicates well with people of all ages and backgrounds. Excellent eye for detail enabling quick identification of areas for improvement and suggesting strategies to help businesses reach goals. Focused on introducing efficient systems and processes.
Overview
8
8
years of professional experience
4
4
years of post-secondary education
1
1
Certification
Work History
Principal Consultant
Vitrana Pvt Ltd
Noida
03.2018 - Current
- Knowledge of Global Pharmacovigilance & Global Regulatory Guidelines.
- Strong Experience in identifying, analyzing and translating business requirements into solutions
- Played main role in Installation, configuration and E2B R3 profile creation in Argus for PMDA, CDR/CDE(China), FDA Combo Products, MFDS, COFEPRIS, EUMIR PDF, EDQM Implementation for leading Pharma Industries across the Globe.
- Experience of installation of BFC tools, Safety tools in both Windows and Linux platforms.
- Sound knowledge of E2B R3 and R2 Profile customization for both Inbound and Outbound. Resolved Argus Safety import related issues.
- Played main role in Installation of Oracle Empirica Signal, setting up a completely new environment including a database and a server for customer.
- Implementation of Argus Mart 7.0.3.3 and Oracle Data Integrator.
- Consulting over business requirements and provide technical solutions for the same which cannot be met with out of the box Argus Safety Suite.
- Sound knowledge of drafting IQs, OQs and PQs. Well versed with Oracle PL/SQL and SQL concepts.
- Worked in Argus Upgrade projects mainly for E2B profiles, configurations, infrastructure management, etc.
- Worked in ARISG to ARGUS Migration project in development of Framework and few tables migration.
- Development of new export profile for EUMIR PDF in Argus 8.2 and importing generated XML into EU-MIR PDF.
- Well versed with Argus Safety Business Configuration and Flexible codelists.
- Proficient in updating and writing DTD and XSLT files as per solution requirements.
Assistant Systems Engineer
Tata Consultancy Services Ltd
Noida
11.2015 - 03.2018
- Support and Enhancement of Oracle Argus Safety Application while working in a L3 Support project for a leading Japan bases Pharmaceutical company.
- Customizations of E2B profile Inbound and Outbound as per business requirements.
- Creation or Modification of reporting rules, advance conditions, auto-narratives and workflow rules.
- Performed WHO Drug, MedDRA and J-Drug upgrade.
- Comfortable in working with Japan business culture.
- Provided resolution to customer reported incidents and change requests within defined SLA.
- Creation of community and routing IDs on AXWAY using TLS1.2 and TLS 1.0 encryption algorithm.
- Well versed with writing SQL to generate line listing as per business requirements.
Education
Bachelor of Technology - Electronics And Communication
Govt College Kota, Rajasthan Technical University
Kota 07.2011 - 04.2015
Skills
Argus Safety/ J
Certification
Japanese Language Proficient Test N4
Timeline
Principal Consultant
Vitrana Pvt Ltd
03.2018 - Current
Japanese Language Proficient Test N4
07-2016
Assistant Systems Engineer
Tata Consultancy Services Ltd
11.2015 - 03.2018
Bachelor of Technology - Electronics And Communication
Govt College Kota, Rajasthan Technical University
07.2011 - 04.2015
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