Business Process Expert
- Hyderabad, India
530+ active trials with 80,000 patients; 9+ million case reports per year; 1 Regulatory submission every 6 minutes! As the technology and innovation Partner, Development IT supports every stage of drug development by delivering end-to-end service offerings. Join us and directly contribute to Novartis' vision to ReImagine Medicine.
• Develop project rationale and perform scoping assessments to determine feasibility of projects, Highlight/identify gaps in existing functionality and review requirements with stakeholders
• Develop a comprehensive requirement specifications that will determine the estimate of cost, time and resources to deploy solutions, Liaise with the service development team to suggest a high level functional solution
• Develop project estimates and complete financial model (costs, savings, revenue opportunities, investment horizon, etc.),Ensure that relevant stakeholders are involved in specification of new services and/or major upgrades to existing services
Ensure the overall user experience is taken into account when designing and deploying new solutions and services, Ensure consistency and traceability between user requirements, functional specifications and testing & validation. Support validation and testing (OQ, PQ, UAT...)
• Ensure implemented solutions are according to specifications and fit for purpose, Support super user training, Keep abreast with internal IT systems and documentation requirements, standards (including quality management and IT security), industry best practices in leveraging technologies for the business and with regulatory environments / requirements if applicable
Take accountability to ensure adherence with Security and Compliance policies and procedures within Service Delivery scope
• Consult with customers on best suited Argus configuration approaches
• Willingness and ability to learn new platforms to carve out next generation Safety systems.
o Bachelor degree in engineering (BE/BTech) or computer science or related area.
o 12+ years of experience in a similar role with a proven track record in building large scale solutions.
o At least 5+ years of hands-on development/implementation experience on ARGUS or similar Safety system, Deep knowledge of Pharmacovigilance domain and overall knowledge of Pharmaceutical industry
o Experience in Argus upgrades and releases. Operations management is desired, Understanding of business rules configuration and PV analytics is a plus.
o Experience in working with GxP Systems validation and compliance is desirable, Experience working with Agile methodologies and other project management is advantageous.
o Expert understanding of business process analysis & design and system architecture, Proficient skills in teamwork, collaboration, facilitation, negotiation, working in a matrix environment and conflict resolution, Experience in working with global, multi-cultural and matrix environment
Why consider Novartis?
799 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
Imagine what you could do at Novartis!
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