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    Project Specialist - Periodic Report Expert (Pre)

    Sanofi
    2-4 years
    Not Disclosed
    Hyderabad Mumbai
    10 Aug. 13, 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, 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: Project Specialist - Periodic Report Expert (PRE)

    Grade: N/A
    Hiring Manager: Head Scientific Communications/Project Manager
    Location: Hyderabad/Mumbai
    Travel: As per business needs
    Job Type: Permanent, Full-time

    About the Job

    Our Team:

    Sanofi Business Operations is an internal resource hub in India, established to centralize and streamline processes for supporting Specialty Care, Vaccines, General Medicines, CHC, CMO, R&D, and Data & Digital functions. The goal is to be a strategic and functional partner for global tactical deliveries across Medical, HEVA, and Commercial organizations within Sanofi.

    Main Responsibilities:

    • Benefit-Risk Evaluation: Assess the Benefit-Risk profile of Sanofi’s marketed medicinal products to ensure they are safe and effective for patients.
    • Periodic Safety Reports: Support the preparation of periodic safety reports, including the Addendum to Clinical Overview (ACO).

    Essential Job Duties and Responsibilities:

    1. Project Kick-Off: Conduct meetings to align line functions with periodic report planning requirements.
    2. Coordination & Project Management: Ensure timely receipt, completeness, and incorporation of information into the ACO template, adhering to regulatory requirements.
    3. Organizational Skills: Manage and prioritize multiple requests to meet Sanofi’s business needs.
    4. ACO Authoring: Write assigned sections of the ACO and coordinate with line functions for the assembly of the complete report.
    5. Data Validation: Conduct quality checks, consistency checks, and resolve discrepancies across documents.
    6. Peer Review: Perform quality control (QC) on ACOs and support audit readiness.
    7. Process Improvement: Engage in initiatives aimed at improving processes.
    8. Collaboration: Work effectively with various Sanofi functions, such as Medical, Regulatory, Pharmacovigilance, and external partners.

    People Responsibilities:

    1. Stakeholder Relationships: Maintain effective relationships with stakeholders to ensure comprehensive aggregate analysis meets Health Authority requirements.
    2. Project Leadership: Lead assigned projects and operations activities within Sanofi Global Hub.
    3. Technological Updates: Embrace and leverage new technological developments.
    4. Timely Reporting: Ensure timely completion of reports within specified regulatory timelines.
    5. Technical Support: Provide guidance on electronic document management, ACO, and GVP guidelines.
    6. Vendor Coordination: Oversee and manage vendor activities, providing technical support and ensuring effective interaction.

    Performance Responsibilities:

    1. Timely Delivery: Ensure ACOs are prepared, archived, and delivered as per Sanofi’s quality standards and timelines.
    2. Quality Review: Serve as an independent quality reviewer for ACOs to ensure compliance with regulatory and Sanofi standards.

    Process Responsibilities:

    1. Project Delivery: Ensure high technical standards, efficiency, and quality for periodic safety reports.
    2. Quality Enhancement: Contribute to enhancing the overall quality of output produced by the CMO group.
    3. Compliance: Adhere to regulatory and operational risk controls.
    4. Transversal Activities: Mentor new team members, conduct training, and participate in developing new tools and initiatives.
    5. Inspection Support: Assist with Health Authority inspections, audits, and the development of corrective and preventive actions (CAPA).

    Stakeholder Engagement:

    • Collaborate with CMO and vendor teams to ensure timely deliverables.
    • Liaise with the CMO team for customized deliverables.

    About You

    Experience:

    • 2-4 years in pharmacovigilance, clinical drug development, or related fields.
    • Minimum 2 years of experience in authoring and coordinating periodic safety reports.

    Soft Skills:

    • Stakeholder management, project management, negotiation, communication, and global cross-functional collaboration.

    Technical Skills:

    • Proficiency in MS Office tools, electronic document management systems (preferably Veeva-vault), and Adobe Acrobat.
    • Knowledge of ACO and periodic report authoring, GVP regulations, and the drug development process.

    Education:

    • Graduate/Post-graduate degree in Pharmacy (preferred) or Life Sciences.

    Languages:

    • Fluent in English (verbal and written).

    Why Sanofi?

    Sanofi is committed to progress, driven by people who desire to make extraordinary things happen. 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 and explore our Diversity, Equity, and Inclusion initiatives.

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