Sanofi Group Analytic Reporting Expert in Bridgewater, New Jersey
This position reports to the Analytic Reporting Manager for System Support & Data Management and is responsible to provide business analysis, project guidance and subject matter expertise within Global Pharmacovigilance (GPV)Operations on Analytic Reporting and Data Management. This role will work with System Support & Data Management staff, the end Users and technical teams serving as an advisor/subject matter expert for Business Analytic Reporting process changes and system enhancements. This role will also serve to anticipate business system trends in Analytics and provide expert advice on the business requirements and implementation of new Analytic reporting processes and tools and provide technical leadership with system upgrades and/or continuous improvement projects.
Within the System Support & Data Management, this expert role will advise and contribute to Analytic reporting projects and initiatives to enable GPV to continually increase its productivity while supporting the evolution and sustainability of the PV database and analytic tools. This role will support the emergence of new reporting technologies while ensuring the GPV database and supporting tools are meeting the needs of the PV Users.
This position requires multiple interfaces within PV Operations, GPV as well as across the Analytic reporting user community, health authorities, Quality, ITS and sanofi partners. The role requires experience in managing and leading complex issues in a global environment.
This position is an individual contributor but will be expected to represent the Analytic Reporting Manager when needed, notably during Inspections and Audits.
This position requires a high degree of end user focus and data management while interfacing with partners and customers within and outside of Sanofi (this includes all R&D, Affiliates, and commercial partners with which we have pharmacovigilance data exchange agreements). It requires experience in managing complex issues in a global environment.
Expert support for the operational strategy for analytic reporting.
This role will be a subject matter expert and work with all aspects of Analytic reporting. Specifically, to take reporting strategies and imperatives and drive integrated data and configuration approaches transversally within GPV, ITS and PV consumers for data-driven analytical reporting deliverables required to support GPV strategic initiatives and to ensure the organization’s ability to provide data-driven responses to Health Authorities and business issues.
Drive the emergence of new reporting technologies in PV through the understanding of GPV Strategies and Health Authority expectations.
Develop and implement tactical and execution plans to ensure the PV reporting solutions are meeting the organizational needs efficiently. Additionally, to support all the operational activities of the team and define the corrective actions needed to ensure operational excellence (define processes, metrics, remediate technical gaps that currently exist).
To provide subject matter expertise for the implementation of new processes/tools to improve PV analytical reporting tools/solutions and manage partner processes.
Work collaboratively with the project manager/ITS leader project activities with respect of the internal methodology.
Ensure timely and proactive communication with the users to respond to changing requirements in reporting.
Support the definition and implementation of change initiatives focused in analytic reporting aligned with the vision and strategies of SSDM.
Ensure compliance with relevant policies and procedures.
Working across the GPV organization, partners and stakeholders to establish a transparent, scalable and responsive analytic reporting support model to meet the growing needs of the GPV department.
Support the troubleshooting of analytic reporting system issues, propose solution options.
Interface with IS and System Support & Data Management System Support & Data Management departments to ensure that user requirements are understood for any system changes to ensure that final system deliverables and end results meet the end users’ needs.
Minimum of Ph. D. or Pharm D. (or equivalent experience) with a minimum of 10 years of pharmaceutical industry experience within R&D and/or pharmacovigilance.
Strong experience in Pharmacovigilance systems, Project Management, IS and validation is required. Incumbent should have experience in Pharmacovigilance Safety Data Management, including Analytical Reporting.
Strong computer science technical skills are 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.
Strong knowledge in pharmacovigilance principles and regulatory requirements.
Strong knowledge in Analytic Reporting processes, tools and data management.
Strong clinical as well as technical skills are required. Project Management skills as well as understanding of the different business functions within pharmacovigilance including case management, quality & compliance, signal detection, aggregate & analytical reporting.
Ability to lead and work within multi-disciplinary teams and interface with upper level management of support and client organizations. Strong interpersonal skills to be effective in the leadership of global teams.
Excellent critical data analysis skills (clinical/systems/processes/compliance).
Excellent teamwork and interpersonal skills.
Excellent organizational and planning capabilities.
Excellent communication skills (oral/written).
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.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.