Manager PS Data Operations & Analytics

The Manager PS Data Operations Analytics contributes to the definition and execution of the Sandoz Patient Safety Data Strategy in collaboration with colleagues and technology vendors within the Patient Safety Data Operations Analytics group to ensure high quality and integrity of Sandoz Patient Safety Data. This includes oversight of the configuration of the Safety DB in relation to Sandoz Products, Market Authorizations and Vigilance Partners, as well as Pharmacovigilance related data migrations in the context of Mergers, Acquisitions and Divestments. In addition, the Manager PS Data Operations Analytics acts as Business System Owner of a portfolio of Systems and Applications within Sandoz Patient Safety. Responsible for improvement and Life Cycle Management of these in close collaboration with relevant Business Process Owners and key users to maximize business outcomes for Sandoz Patient Safety. Oversees operational technology teams, external and internal, in terms of operational performance of the technology portfolio, adherence to appropriate IT methods and configurations following change control and GxP Validation processes. Supports audits and inspections with provision of data and listings, and follows up on requests for information and documents.
Supports a global client base and collaborates with many internal teams (Development IT, Regulatory Affairs, Clinical Development), and external technology and services business partners.

• Contributes to the definition and execution of the Sandoz Patient Safety Data Strategy and provides oversight to its implementation in the configuration of the Safety DB, the generation of Line Listings and Reports
• Coordinates internal and external teams in connection with Mergers, Acquisitions and Divestments, and adherence to defined standards and methods for data migrations including oversight of proper execution
• Contributes in driving Global Sandoz Patient Safety Data and Technology strategy, PS systems and worldwide compliance with safety regulations, for pharmaceutical products and devices.
• Develops and maintains Systems Strategy and road map in close collaboration with Patient Safety Business Process Owners, key users and Development IT, including Project Delivery
• Manages systems life cycle (SLC) in collaboration with IT; systems operations, configurations, Business Continuity Plans (BCP), including overseeing performance / governance of external service providers for IT systems
• Collaborates with internal, external stakeholders and vendors to drive innovation, automation and technology advancement, including representation in user groups for key systems
• Represents Head of PS on PV strategy, and operational issues - represent PS in global / cross-functional process, performance or system related initiatives
• Ensures pharmacovigilance inspection readiness and support inspections and audits as required.

What you ll bring to the role: Essential Requirements:

• Bachelor Degree in Life Sciences or Information Technology desirable.
• Clinical experience highly desirable. At least 7 years industry experience; broad experience in Patient Safety; knowledge of drug safety regulatory requirements
• At least 5 years experience in drug development in the area of Patient Safety and related Information Technology
• At least 3 years experience in Life Cycle management of business systems with a global user base

• Thorough understanding of core Patient Safety technology components and Data, such as Safety DB, Case In-take systems, HA Gateways etc, and configuration of those
• Proficient in managing external vendors
• Experienced with SQL and advanced Analytics Tools
• Good understanding of MedDRA, Disease dictionaries
• Familiar with supporting regulatory inspections, responding to inspectors and managing related team actions
• Strong interpersonal and collaboration skills