Overview of the Organization
Oracle Health Sciences GBU (Global Business Unit) provides industry leading solution to Life Sciences organizations including Pharmaceutical companies, CROs (Contract research Organizations), Academic research and Healthcare providers that include care providers, IDN (integrated delivery networks), public regional/national healthcare organizations. The portfolio of Oracle Health Sciences includes industry leading Cloud and/or on-premise solutions for eClincial (EDC, CTMS, Clinical Analytics, and Clinical Warehousing), Safety, Pharmacovigilance and signal detection, Healthcare interoperability, Enterprise Healthcare analytics and Translational Research.
Health Sciences Consulting India is the offshore (India) arm of Oracle HSC (Health Sciences Consulting) that provides services offering to the customers using Oracle Health Sciences products globally. The services include product implementations, upgrades and migration, expert services on Oracle health sciences products and managed services.
Health Sciences Consulting India is looking for Principal consultant- Argus Solutions Lead. Primary role of the consultant is to contribute and lead end to end drug safety system implementation which covers customer interactions, conduct workshop, requirement gathering, develop solutions and design, process optimization, system configuration, validation & testing, provide training , system installation , and post production support.
Typical projects include implementation, customization, upgrades & enhancements of Oracle Health Sciences products both on-premises and on cloud. Principal consultant shall take complete ownership of end to end activities during product implementation cycles by providing domain, Oracle drug safety products & services and solution skills in an individual as well as team capacity.
Key technical areas include Pre Sales support, Argus safety solutions, Pharmacovigilance Operations, Pharmacovigilance Systems, PV, Argus Product Configuration, Data migration, computer System Validation (CSV), GAMP5, E2B R2/R3, and Implementation.
Key responsibilities include
- Support presales activities; develop response for proposals, Argus safety solutions, approach, estimate effort and pricing.
- Lead the customer meeting during the presales discussion, negotiate and contribute in contracts development.
- Planning, managing, executing and closure of various tasks involved in drug safety system implementation
- 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 improvements that is in line with ISPE’s GAMP 5 principles.
- 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.
- Very good understanding of Argus Safety Database
- Strong end to end Argus system implementation experience for Global and Japan customers.
- 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
- Experience Argus Product configuration, upgrade and data migrations
- Experience in Computer System Validation (CSV) and Testing
- Good knowledge on GxP regulations – GAMP 5, 21 CFR Part 11, Annexure 11 , E2B R2/R3 regulatory guidelines.
- Exposure to PL/SQL programing , OBIEE, BIP would be plus
- Strong customer management skills
- 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.
- Experiences in Pharmacovigilance Operations
- Minimum 10+ years’ experience in the IT/ Software solutions and services industry.
- 8+ years of experience in Argus safety system implementation.
- Very good experience and knowledge of the Pharmacovigilance system and database.
- Very strong Presales, Solution Design , System configuring, Reports development ,Validation and Testing experience
- Minimum of 3 Years of experience as a Lead and mentor the team
- Minimum of Bachelor’s degree.
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.