CHC PV Data Strategy and Management Head

• Location: Bridgewater, NJ

• Remote Work: Hybrid

• Travel Expected: Minimal

• Job Type: Full Time

About the Job

At Sanofi Consumer Healthcare , we have one overarching mission - to work passionately, challenging ourselves and our industry every day, to build a healthier future by helping people, help themselves, bringing “Health in Your Hands”.

Our teams are building trusted & loved brands that connect with hundreds of millions of consumers worldwide, enabling better self-care for individuals and communities, while also contributing to a healthier planet. To fulfill this mission, we are embarking our consumers, our customers, healthcare professionals, and our employees in this journey because this is what will make us become the “Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World”.

We strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.

To achieve this, we need strong talent who will help us shape the future of our Consumer Healthcare business and challenge our industry. At Sanofi Consumer Healthcare, we aspire to create a work environment where people can thrive, grow, and be at their best every day. Our priority is working with integrity to improve the health and well-being of people and communities where we operate, working towards making a positive impact in the world.

Our Team:

This position will report to the CHC PV Operations Head and is responsible for providing the strategic vision, planning and oversight on CHC PV systems and data management solutions, including the Global pharmacovigilance database. Responsibilities will include Reporting, Configuration, Data Migration, E2B management, Validation, system releases, user access management and service management tasks.

This person will have oversight and responsibility for PV safety data management needs including the identification of new systems necessary to support the PV Infrastructure, as well as ensure all systems and databases which are required for PV activities are performing appropriately, utilizing the latest technology. Provide system and administration support to business users within the Consumer Health PV organization including Consumer Healthcare PV Operations, PV Affiliates, PV Compliance, Safety Signal & Risk Management, Global Medical, Regulatory, Quality and other business functions.

This position is accountable for fully validated systems that meet industry standards and are appropriately configured to comply with FDA, EMA and PMDA requirements, as well as other Health Authorities globally.

Main Responsibilities:

• This position is also responsible to ensure that processes and systems are in place to provide for appropriate handling and reporting of safety data and for the identification and management of external vendors/consultants.

• Act as a Business System Owner for all PV systems and tools

• This position is responsible for PV data strategy and data governance.

• Responsible to lead the PV data integration effects with other science hub organizations.

• This Position is also responsible to ensure that the appropriate resources and procedures are in place for timely and accurate reporting of PV information for aggregate and ad hoc reporting needs/data analytics.

• Responsible to maintain PV data privacy as per GDPR & other regulations in PV systems.

• Represent PV in science hub data initiatives such as data lake and other business analytics initiatives.

• Responsible for user access management, CHC PV database configurations, Validation documentation, Change Management and upgrade release implementation.

• Responsible for Safety data Migration acquisitions, mergers and divestments.

• This position is Accountable for resolving and escalating PV system incidents, managing user change requests in collaboration with Digital teams and PV Database hosting Vendor.

• Initiate discussions with business stakeholders to understand PV business requirements, document user requirements and ensure these are prioritized and implemented in collaboration with Vendor & Digital teams.

• Communicate system related messages relevant to all levels of stakeholders, including content and plan of systems releases, issues, etc.

• Plan for scheduled/ad-hoc releases by developing and execution of test scripts. Work in close collaboration with Vendor/Digital teams for the implementation of all releases in ensuring GxP validation requirements are met.

• Responsible for impact assessment as releases move through the development and deployment process. Facilitate support and training sessions for system users.

• Maintain systems access and assessing any impact to systems security due to the introduction of new system features.

• Conduct regular access management reviews to remain in compliance with corporate security policies.

• Responsible for supporting Audit/Assessment/Inspection readiness and lead or participate in system internal audits and/or external inspections as needed.

• Support oversight of vendor assigned staff for managed services, monitoring of KPIs, assist with incidents and escalations as needed as part of governance structure.

• This position requires multiple interfaces with partners and customers within and outside of Sanofi CHC (this includes all science hub and commercial external partners with which we have SDEA).

• Represent Sanofi CHC in Industry Standard procedures forum of LSMV and other industry forums.

• Investigate and deploy Gen AI technologies in PV systems to bring efficiency and cost savings.

Experience

• Experience in PV Databases like LSMV, ARGUS, ARISG, VAULT Safety etc.

• Experience in a systems operations support role within safety/pharmacovigilance as business analyst, configuration manager or business relationship manager

• Experience in leading safety systems in the market

• Experience and understanding of the safety/pharmacovigilance process and regulations, ICH GCP and GxP regarding systems validation and documentation.

• Knowledge of IT systems in the pharmaceutical industry with an emphasis on PV systems. Knowledge of GxP validation processes.

• Good knowledge of PL/SQL and MS Office

• Minimum 10 years of pharmaceutical industry experience with a focus on pharmacovigilance. Strong experience in IS and validation is required.

• Incumbent should have experience in Process Improvement practices.

• Language skills

• Fluent spoken and written English

• An Additional language is desirable.

Education

• Bachelor’s degree in science (or) Engineering (or) Data sciences or any equivalent academic qualification is desirable with 10 years’ experience in PV databases and other GxP systems

Pursue Progress, Discover Extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !

#LI-SA

#LI-CHC

Pursue progress , discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) !