Sanofi Group Validation, Documentation & Metrics Manager - Bridgewater, NJ in Bridgewater, New Jersey

Job Summary

This position reports to the Head, System Support and Data Management (SSDM). The Validation Documentation and Metrics Manager will lead a team of Validation specialists to ensure appropriate validation testing and documentation for on-going support of production systems, the development of new or existing systems as well as the documented evidence that Queries and reports have been independently verified according to internal standards (ad hoc reports). The Manager will be responsible for working with System Support & Data Management members, end users and management to define appropriate Validation Strategy and Testing the system or related subsystems. This role will work closly witht SSDM members involved in the daily operation support of the systems and tools as well as working with the reporting team to ensure queries/reports are tested and validated based on internal standards and procedures. All necessary documentaion to support internal methdology and and regulatory standards are under the responsibility of this role.

This role will also take the lead witin the System Support & Data Management team to ensure that Quality and Perfomance metrics are defined, tracked and reported as part of the System Support & Data Management Continuous Quality improvement initiative.

Major Duties and Responsibilities

  • Lead a team of Validation specialists.

  • Manage objective setting, resource assignment and performance appraisal.

  • Review and approve individual development plans.

  • Responsible for salary and bonus reviews and recommendations.

  • Ensure that appropriate validation activities and documentations occurs to support the sanofi-aventis corporate IS validation methodology. This will allow for consistency in the final system deliverables and ensure consistency with the desires of the users. In addition, this will ensure that the system will withstand regulatory scrutiny      

  • Perform, verify and document the final testing and validation for production systems, new systems, tools and standard reports derived from the System Support & Data Management database system or tools. This will allow for consistency in the final system deliverables and ensure consistency with the desires of the users. In addition, this will ensure that the system will withstand regulatory scrutiny

  • Ensure the Validation of Ad Hoc Reports. Due to the regulatory nature of Ad Hoc Reporting it is critical that our safety reporting is accurate and comprehensive. The validation activity ensures that reports that are analyzed for safety purposes and sent to regulatory authorities accurately reflects our safety data.

  • Define the Interface with end users and management to define business/workflow rules for

  • Ensure that Quality and Performance metrics are defined, tracked and reported as part of the System Support & Data Management Continuous Quality improvement initiative.  

  • Stay abreast of current evolving technology and review it for its applicability for use in GPE. This will allow GPE to continue to be on the cutting edge of technology to maximize its efficiency and effectiveness.  

Knowledge and Skills

  • Ability to lead a team of Validation specialists.

  • Strong understanding of the different functions within pharmacovigilance including workflow, case management rules, and reporting requirements.

  • In depth knowledge of the sanofi-aventis validation methodology, Validation strategy, testing and documentation requirements.

  • Ability to lead author technical documents.

  • Excellent attention to detail.

  • Ability to take a lead rolein multidisciplinary teams and interact with individuals of varying levels

Qualifications

  • Minimum of a BS degree in science or engineering

  • Minimum 10 years pharmacovigilance experience or related knowledge (system validation and testing)

  • Working knowledge of global pharmacovigilance regulations

  • Knowledge And Skills Desirable But Not Essential:

  • Knowledge of Information Systems Business and processes

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