Principal Consultant- Argus and Inform Expert-19000KJD

Preferred Qualifications

• Develop study build design, inform configuration, publish data, and customize reports
• Planning, managing, executing and closure of various tasks involved in drug safety system implementation
• Lead integrations/trial projects in a particular technical stream in all phases of project (Scope, DEV, QA, UAT and Live)

• Collect and analyze of defects and performance metrics created by the teams

• Design and architect solutions for applications and/or application interfaces

• Conduct workshop, Involve in the business discussions with customer’s Pharmacovigilance department executives in order to design the necessary configuration of the Argus Safety Suite, review business process, Impact/gap analysis, develop requirement specification
• Design of Argus Safety suite solution for the customer.
• Design and development of extensive product customization
• Configuration of aggregate reports such as, PADER, DSUR, CSPR etc
• Safety data assessment and develop scripts using PL/SQL programing.
• Conduct end to end implementation of Argus system
• Experience in implementing CSV process and validation packages that is in line with ISPE’s GAMP 5 principles.
• Very strong understanding of product internals, Application data structure and database to resolve complex queries raised by customer
• Strong E2B and ICSR concepts and experience in setting up ESTRI Gateways with health authorities
• Experience in product implementation for Japan customers and understanding of PMDA regulations will be plus
• Contribute to 21 CFR Part 11 and EU Annex 11 compliance
• Build the assets, reusable accelerators, best practices & process for safety system implementation
• Assure the quality of all the implementation documentation
• Support and educate to safety system end users and sponsors
• Triage and analyze issues and provide solutions.

• Domain skills in the area of Health Life Sciences , drug safety and Pharmacovigilance &R&D IT
• Understanding of Clinical and Pharmacovigilance system implementation lifecycle and phases
• Understanding of regulations in the context of drug safety – USFDA, EMA, PMDA
• Hands on development /customization designing/implementation.
• Thorough knowledge of Oracle Health Science Inform product
• Thorough knowledge of Argus Configurations including reporting Rules,Workflows, E2B, Aggregate Reporting, EDI
• Minimum 8 years drug safety regulated environment working experience
• Experience with the Middle tier – ESM module, to configure profiles/DTDs

• Impeccable knowledge on CSV documentation, Validation packages, process, practice, standards and best practices
• Good knowledge on GxP regulations – GAMP 5, 21 CFR Part 11, Annexure 11 , E2B R2/R3 regulatory guidelines.
• Strong customer management skills
• Exhaustive knowledge on SQL
• Good technical writing skills
• Good team management skills
• Must be well organized, and ability to prioritize work
• Ability to work with culturally diverse and virtual teams.
• Ability to work in an onsite offshore delivery model.
• Hands-on working attitude.
• Open to short international travel to customer locations for meetings and discussions.
• Strong business acumen, communication and interpersonal skills.
• Professional with strong planning and analytical skills.

• Minimum 10+ years’ experience in the IT/ Software solutions and services industry.
• 8+ years of experience in Clinical and Drug safety system implementation.
• Good experience with Life Sciences applications- Inform product
• Very good experience and knowledge of the Pharmacovigilance system and database.

• Very strong Solution Design , System configuring, Integration , Validation and Testing experience

• Very strong Oracle database skills, proficient in Oracle PL/SQL, Oracle database, Multiple platforms (Windows, Linux), web service technologies will be an asset

• Data modeling skills
• Minimum of 3 Years of experience as a Lead and mentor the team

• Minimum of Bachelor’s degree.

Detailed Description and Job Requirements An experienced consulting professional who has an understanding of solutions, industry best practices, multiple business processes or technology designs within a product/technology family. Operates independently to provide quality work products to an engagement. Performs varied and complex duties and tasks that need independent judgment, in order to implement Oracle products and technology to meet customer needs. Applies Oracle methodology, company procedures, and leading practices.

Operates independently to provide quality work products to an engagement. Performs varied and complex duties and tasks that need independent judgment, in order to implement Oracle products and technology to meet customer needs. Applies Oracle methodology, company procedures, and leading practices. Demonstrates expertise to deliver functional and technical solutions on moderately complex customer engagements. May act as the team lead on projects. Effectively consults with management of customer organizations. Participates in business development activities. Develops and configures detailed solutions for moderately complex projects.

5-7 years of experience relevant to this position including 2 years consulting experience preferred. Undergraduate degree or equivalent experience. Product or technical expertise relevant to practice focus. Ability to communicate effectively. Ability to build rapport with team members and clients. Ability to travel as needed.