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    Chc Pv Data Strategy And Management Head

    Sanofi
    10yr years
    Not Disclosed
    Bridgewater
    12 June 11, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: 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, our mission is to build a healthier future by empowering people to help themselves, bringing “Health in Your Hands”. We are dedicated to creating trusted and loved brands that connect with millions of consumers worldwide, promoting better self-care for individuals and communities while contributing to a healthier planet. To achieve this, we need strong talent to shape the future of our Consumer Healthcare business.

    Our Team

    This position reports to the CHC PV Operations Head and is responsible for strategic vision, planning, and oversight of CHC PV systems and data management solutions, including the Global pharmacovigilance database.

    Main Responsibilities

    • Strategic Oversight:

      • Act as Business System Owner for all PV systems and tools.
      • Responsible for PV data strategy and governance.
      • Lead PV data integration efforts with other science hub organizations.

    • System Management:

      • Maintain PV data privacy as per GDPR and other regulations.
      • Manage user access, database configurations, validation documentation, change management, and system upgrade releases.
      • Oversee safety data migration for acquisitions, mergers, and divestments.
      • Resolve and escalate PV system incidents, and manage user change requests.

    • Stakeholder Collaboration:

      • Initiate discussions to understand PV business requirements and document user requirements.
      • Communicate system-related messages to stakeholders.
      • Plan and execute test scripts for system releases, ensuring GxP validation requirements are met.
      • Facilitate support and training sessions for system users.
      • Conduct regular access management reviews to comply with corporate security policies.

    • Audit and Compliance:

      • Support audit readiness and lead or participate in system internal audits and external inspections.
      • Oversee vendor staff for managed services, monitor KPIs, and assist with incidents and escalations.

    • Innovation:

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

    Experience and Skills

    • Required:

      • Experience with PV databases like LSMV, ARGUS, ARISG, VAULT Safety.
      • Systems operations support role within safety/pharmacovigilance as business analyst, configuration manager, or business relationship manager.
      • Leading safety systems in the market.
      • Understanding of safety/pharmacovigilance process and regulations, ICH GCP, and GxP validation processes.
      • Knowledge of IT systems in the pharmaceutical industry with an emphasis on PV systems.
      • Proficiency in PL/SQL and MS Office.
      • Minimum 10 years of pharmaceutical industry experience with a focus on pharmacovigilance and IS/validation.
      • Experience in process improvement practices.

    • Preferred:

      • Experience with Gen AI technologies.

    Language Skills

    • Fluent spoken and written English.
    • An additional language is desirable.

    Education

    • Bachelor’s degree in science, engineering, data sciences, or an equivalent academic qualification with 10 years of experience in PV databases and other GxP systems.

    Equal Opportunity Employer

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

    Apply Now

    Join us in making a positive impact on the health and well-being of people and communities where we operate, and be a part of a team that strives to make a difference every day.

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