To provide quantitative analytical support for PS&PV by ensuring timely delivery of high quality reports to meet regulatory requirements, enable medical safety analysis and monitor safety profile of Novartis products. Build capabilities to leverage the Science of data to enhance safety surveillance, case management and delivery of management metrics. These tasks are to be performed independently. Responsible for independently managing medium to critical Projects.

• Analytical reporting system ownership, accountability, and responsibility to keep the system healthy and improve it based on functional users future reporting needs
• Engineer key analytical reporting insights into simple, intuitive, and well-designed tools and services tailored for each role and process:
  • Aggregate analysis and reporting
  • Risk-based operational monitoring
  • Detecting data anomalies, outliers, and procedural errors
  • Track the business’s performance against data analysis model and monitor trends in key business KPIs, providing valuable insights to relevant departments for overall business performance improvement.
  • Broad understanding of drug development – Early development, clinical trials, safety, data management, etc.
• Ability to lead the development of big data capabilities and utilization as well as the coordination of cross-functional analytic initiatives.
• Work with partners in IT, Business functions, Service partner, Product vendors and internal process experts to improve the availability of data (near-real time data flows) and data quality as required for high quality, innovative, analytical/technical solutions by providing analysis and interpretation of Safety and PV data with a consulting and advisory mindset.
• Act as deputy of Head Data Science and Analytics / Team Manager Data Science as and when needed. Ensures that the interests of PS&PV are represented at internal and external meetings and forums as appropriate including senior leadership PS&PV meetings. Participate and contribute for PS&PV Strategy.
• Oversight of performance of technology product. Provide continuous improvement plans in collaboration with relevant technology teams. Ensure technology product is in compliance with GxP, Novartis CSV and Quality standards. Host Voice of Business forum and SteerCo for technology product.
• As Business System Owner participate in interdisciplinary team of functional SMEs and end-consumers to independently assess opportunities for simplification of technology landscape as well as new external opportunities. Drive user-centricity in our approach to developing solutions by embracing design thinking methodologies and collaborating with User Experience experts.
• Through feedbacks and surveys, leverage customer insights and a deep understanding of the technology product to forecast, plan, and manage the customer needs for future enhancement / issue resolution.
• Monitor performance of Technology Product and proactively identify systemic risks & issues and take appropriate corrective and preventive actions.
• Represent product/system in audits and inspections. Keep track on successful and timely closure of CAPAs arising from inspections and audits. Submit deviations on time.

Role Requirements

• Education : Information Technology or related field. BE, BTech, MCA, MTech in Computer Science or equivalent.
• Languages: Fluent in spoken and written English.

Skills / Experience:

• Experience in pharma drug development preferred, ideally in patient safety
• Experience in an international, cross-functional environment preferred – including management of external providers
• At least 5 to 7 years of data warehouse modeling, architecture – ETL, data services, MDM/RDM – and operations. Demonstrated experience with ORACLE databases, PL/SQL, Other ETL, Data Lake and Analytics Reporting tools
• Understanding of patient safety, clinical development, quality and regulatory standards and policies relevant to PS&PV functions, or familiarity with operational and scientific aspects of drug development preferred
• At least 5 years of experience working within IT projects, with a thorough understanding of the issues revolving around aligning technology with business needs
• Experience supporting regulatory inspections, responding to inspectors and managing related team actions
• Strong interpersonal and leadership skills