Sanofi Group Business Analyst Manager, System Support and Data Management (SSDM)- Bridgewater, NJ in Bridgewater, New Jersey

Job Summary

Business Analyst Manager role encompasses many of the operational aspects within the System Support and Data Management unit. This role works directly all GPV stakeholders, including GSOs, PV Scientists, to accurately interpret and translate business needs into the appropriate technical language to ensure that configuration, operations, validation, and/or analytic reporting deliverables meet business needs. This role is responsible for the oversight and management of various aspects of the safety database system as well as direct involvement and oversight of projects designed to deliver enhancements, change controls and future tools to support GPE.

Additionally, the Business Analyst Manager will have oversight for multiple vendor activities supporting the SSDM team. The incumbent works with all SSDM stakeholders to ensure accurate planning and execution of critical database system activities.

The Business Analyst Manager can also participate in the configuration of the safety database as well as the development, validation and maintenance of the system enhancements including the generation and approval of documentation to support the Sanofi methodology PUMA (Project Unified Methodology Approach). It is important that the Business Analyst has a strong PV knowledge and working relationships with the user community as well as the Information Technology (ITS) department.

Principal Duties and Responsibilities

  • Responsible to liaise with GPV client base to interpret, collect, analyze, develop and implement all configuration requests received from PV database end users, country offices, partners, health authorities etc.

  • Ability to interpret business needs into database requirements and ensure successful implementation into the PV database and provide clear and concise direction to technical outsourced staff. Responsible to ensure 100% accuracy , perform quality checks following SSDM established processes on all configuration requests

  • Support daily operations and maintenance of the global PV database by delivering a validated PV database with high degree of reliability and users satisfaction

  • Ensure desired configuration, compliance, business process, data integrity, quality, validation, security and system governance objectives under the responsibility of SSDM.

  • Responsible and accountable for timely escalation of issues and concerns that impact the GPV business, collaboration and efficient working of the team to the PV Database Operations Manager.

  • Work effectively with Sanofi internal and external stakeholders on cross-functional projects on behalf of SSDM (e.g. Case process Regionalization and Automation)

  • Interface with users to ensure understanding of the request, suggest strategies for handling the request, and provide target date for delivery of the report.

  • Support testing and validation of changes to the PV Database. Generate appropriate documentations to support the Sanofi ITS validation methodology.

  • Collaborate with ITS and 3rd party providers to ensure GPV business operational efficiency (per Service Level Agreement) adhering to SLA, meeting KPIs and meeting business needs

  • Responsible for working with end users and GPE to define business requirements for the system or related sub systems.

  • Responsible for troubleshooting system issues as they arise and working with the ITS departments to ensure rapid resolution of the problem.

  • Generate PUMA documents required for system development in particular requirements specification, validation strategy and user acceptance testing. These documents are needed for the development/maintenance of computerized systems to ensure the conformity of the system with the end users requirements.

  • Interface with ITS, 3rd Party Vendor(s) and GPV functional areas (PV Operations, Affiliates, Quality, Global Safety Sciences) to ensure that user requirements are understood for any PV Database changes (planned or unplanned) and allow for consistency in the final system deliverables and ensure that the result meets the end users’ needs

Knowledge And Skills

  • Minimum 10 years total experience in international global pharmacovigilance activities including experience in data systems implementation, post-marketing and/or clinical development pharmacovigilance.

  • Understanding of the principles and goals of Pharmacovigilance.

  • Vendor management experience

  • Knowledge of Oracle database, SQL

  • Ability to manage a team of Data Base experts

  • Critical data analysis skills (systems/processes/compliance).

  • Teamwork and interpersonal skills

  • Organizational and planning capabilities

  • English Communication skills (oral/written)

Formal Education And Experience Required:

  • BS degree (science, engineering, computer science) or previous experience in Pharmacovigilance Safety Database/validation experience working in a highly regulated environment

  • Strong technical skills are required. Strong Pharmacovigilance data systems experience is required.

  • In-depth knowledge of International pharmacovigilance requirements/ EU, FDA requirements/international guidelines, ICH/CIOMS, with experience in their practical application

  • In-depth understanding of pharmacovigilance processes, regulatory compliance and needs of standardization. Knowledge of GCP and validation of computerized system methodology.

  • Knowledge on a query tool (BI, Business Objects, OBIEE) desirable

  • Previous experience working with Argus safety database

  • Previous experience in computerized system methodology for implementation and validation of IT systems

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life