CHC PV Data Strategy and Management Head - Morristown, NJ

About the Job

Sanofi Consumer Healthcare is seeking a vigilant and dedicated professional for the position of Pharmacovigilance Case Management Head. If you have a keen eye for detail, a passion for pharmacovigilance regulations, and a commitment to maintaining the highest standards of drug safety, we invite you to apply. Be part of our mission to safeguard public health and make a meaningful difference in the pharmaceutical industry.

At Sanofi Consumer Healthcare, we build trusted and loved brands that connect with hundreds of millions of consumers worldwide. Our mission is to enable better self-care for individuals and communities, while also contributing to a healthier planet. We strive to act as a force for good by integrating sustainability in our business practices and employee missions, and we operate responsibly from both a social and environmental point of view. To achieve this, we need people who can shape the future of our business and help us on our journey to becoming the best fast-moving consumer healthcare company in and for the world.

Main Responsibilities

• Ensure that processes and systems are in place 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.
• Manage PV data strategy and data governance.
• Lead the PV data integration efforts with other science hub organizations.
• Maintain PV data privacy as per GDPR and other regulations in PV systems.
• Represent PV in science hub data initiatives, such as data lake and other business analytics initiatives.
• Manage user access, CHC PV database configurations, validation documentation, change management, and upgrade release implementation.
• Resolve and escalate PV system incidents, manage user change requests in collaboration with Digital teams and PV Database hosting Vendors.
• Initiate discussions with business stakeholders to understand PV business requirements, document user requirements, and prioritize implementation in collaboration with Vendor & Digital teams.
• Communicate system-related messages to all levels of stakeholders, including content and plan of system releases.
• Facilitate support and training sessions for system users.
• Support audit, assessment, and inspection readiness; lead or participate in system internal audits and/or external inspections as needed.
• Oversee vendor-assigned staff for managed services, monitor KPIs, and assist with incidents and escalations as needed.
• Represent Sanofi CHC in Industry Standard Procedures forums, such as LSMV and other industry forums.

About You

• Bachelor’s degree in science, engineering, data sciences, or any equivalent academic qualification.
• Minimum 10 years of experience in PV databases and other GxP systems.
• Experience in the pharmaceutical industry with a focus on pharmacovigilance is essential.
• Strong experience in IS and validation.
• Experience with PV Databases like LSMV, ARGUS, ARISG, VAULT Safety, etc.
• Experience in a systems operations support role within safety/pharmacovigilance as a business analyst, configuration manager, or business relationship manager.
• Understanding of safety/pharmacovigilance process and regulations, ICH GCP, and GxP regarding systems validation and documentation.
• Knowledge of IT systems in the pharmaceutical industry, especially PV systems and GxP validation processes.

Why Choose Us?

Join Sanofi Consumer Healthcare to bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career through promotions or lateral moves, at home or internationally. Enjoy a well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family with a wide range of health and wellbeing benefits, including high-quality healthcare, prevention and wellness programs, and at least 14 weeks of gender-neutral parental leave. You'll grow alongside a talented team motivated by a shared purpose.

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,