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    Pv Publishing Expert

    Sanofi
    6+ years
    Not Disclosed
    Hyderabad
    10 Dec. 13, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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: Pharmacovigilance Publishing Expert
    Location: Hyderabad, India
    Job Type: Permanent, Full-time
    % of Travel Expected: As per business need

    About Sanofi

    At Sanofi Consumer Healthcare, our mission is clear: to create a healthier future by empowering people to take charge of their health. With our trusted brands and strong commitment to sustainability, we aim to improve self-care globally. We value innovation, collaboration, and integrity, striving to be the best in the fast-moving consumer healthcare industry. Join us to shape the future of healthcare and make a lasting impact on communities worldwide.

    Position Overview

    As part of the Consumer Safety organization, under the direction of the Global Science CoE Lead, the Pharmacovigilance (PV) Publishing Expert will be responsible for overseeing and managing the distribution of Periodic Safety Reports (PSRs) and the overall PV publishing activity. The role ensures the successful publishing of all CHC PV regulatory documents, manages global publishing vendors, and guarantees compliance with regulatory requirements for report submissions.

    Key Responsibilities

    • Document Management & Publishing:

      • Ensure compliant publishing of Periodic Safety Reports (PSRs) for submission to regulatory agencies.
      • Manage the electronic Document Management System (eDMS) and publishing systems, ensuring timely and high-quality submissions.
      • Oversee the coordination, publishing, and tracking of PV regulatory submissions.

    • Vendor Oversight & Stakeholder Collaboration:

      • Act as the main point of contact for global publishing vendors, ensuring they adhere to quality standards and timelines.
      • Provide training and mentoring to PV personnel and vendor staff on document management and report publishing activities.
      • Liaise with the Risk Management Plan (RMP) unit and regulatory units to ensure that data and templates are properly uploaded into eDMS.

    • Process Improvement & Training:

      • Continuously improve standards, procedures, and systems to meet evolving regulatory requirements and best industry practices.
      • Develop training materials and conduct training for PV personnel on the use of eDMS and MS Word features.

    • Support Special Projects & Submissions:

      • Lead PV-related special projects focused on publishing and document management.
      • Oversee the publishing and submission of Global PSMF in collaboration with the QPPV Coordinators.
      • Provide Veeva Vault and publishing support for various safety documents, including regulatory response documents and adhoc safety reports.

    • Collaboration & Stakeholder Management:

      • Act as the primary contact for countries and regions on all matters related to PSR distribution.
      • Work closely with the CHC PSR team and external partners to ensure deliverables meet regulatory standards.

    Experience & Skills

    • Experience:

      • 6+ years in pharmacovigilance or drug safety, preferably in consumer healthcare or pharmaceuticals.
      • Strong understanding of global PV regulations and guidelines (e.g., FDA, EMA, ICH).
      • Proven experience in managing complex issues in a global environment.
      • Experience in mentoring and managing teams of PV professionals.

    • Soft Skills:

      • Strong project management, communication, and interpersonal skills.
      • Strategic thinker with the ability to work independently and within cross-functional teams.
      • Excellent analytical and problem-solving skills.

    • Technical Skills:

      • Experience with electronic Document Management Systems (eDMS) and Report Publishing Systems.
      • Advanced proficiency in MS Word, Adobe Acrobat, and Excel.
      • Expertise in determining best practices for eDMS system activities and change controls.
      • Basic knowledge of PV/safety databases and regulatory submission activities.

    • Education:

      • Master's degree in life sciences or a related field (e.g., Pharmacy, Medicine, Biochemistry, Biophysics, Microbiology, Biotechnology).

    • Languages:

      • Excellent proficiency in English (spoken and written).

    Why Sanofi?

    At Sanofi, we offer a collaborative and inclusive environment where employees can thrive and grow. We are committed to providing equal opportunities to all, regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. We believe that diverse perspectives drive innovation, and we strive to make a positive impact in the world through our people, products, and actions.

    Join Us in Pursuing Progress

    Together, we can make extraordinary things happen. If you are passionate about improving healthcare and making a global impact, we encourage you to apply and become part of our dynamic team.

    Pursue Progress. Discover Extraordinary.
    At Sanofi, we aim to transform healthcare and improve lives. Join us in making a difference!

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