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    Analyst – Patient Oriented Programs

    Novartis
    2+ years
    Not Disclosed
    Hyderabad
    10 Sept. 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:

    Analyst - Patient-Oriented Program

    Division: Operations

    Business Unit: CTS

    Location: Hyderabad, India (Office)

    Company / Legal Entity: IN10 (FCRS = IN010) Novartis Healthcare Private Limited

    Functional Area: Marketing

    Job Type: Full-time

    Summary

    As an Analyst for the Patient-Oriented Program (POP), you will be responsible for managing and ensuring the compliance of POP activities from end to end. Your role includes liaising with cross-functional teams to facilitate the successful execution of the program, adhering to applicable processes and quality standards.

    About the Role

    Key Responsibilities:

    • Program Administration:

      • Manage the end-to-end POP process in line with the Doing Business Ethically (DBE) policy and POP Standard Operating Procedures (SOP).
      • Coordinate with all POP stakeholders, including POP Champion, Procurement, Legal, Patient Safety, Compliance, and Quality Assurance to create necessary POP documentation.

    • Approvals and Compliance:

      • Obtain timely approvals for POP execution and manage compliance checks of External Service Providers (ESP) before fieldwork initiation.

    • Data Management:

      • Enter program details into the POPsys database and monitor all related activities (e.g., First Participant First Contact, Last Participant Last Contact, Adverse Event Reconciliation).
      • Track and ensure timely completion of program milestones and prevent monitoring gaps before program closure.

    • Documentation and Quality Management:

      • Maintain detailed documentation of all POP activities in the POP repository.
      • Address quality issues by documenting them in the Quality Issue (QI) management tool, and carry out investigations, root cause analyses, and corrective actions.

    • Stakeholder Engagement:

      • Ensure effective handover of responsibilities during role transitions or planned leaves.
      • Manage assigned projects effectively, escalate findings as needed, and seek feedback for continuous improvement.

    Essential Requirements:

    • Experience:

      • 2-5 years of experience in the pharmaceutical industry within Clinical, Pharmacovigilance (PV), Medical/Regulatory Affairs, or related compliance or commercial roles.

    • Knowledge:

      • Good understanding of local regulatory requirements and policies in the pharmaceutical industry.

    • Skills:

      • Effective communication skills across various organizational levels and teams.
      • Proficiency in managing compliance and program activities.

    Desirable Requirements:

    • Education:
      • College or university degree in security, criminal justice, crisis management, business continuity, or related fields. Advanced degree (e.g., Master’s or MBA) is highly desirable.

    Why Novartis? At Novartis, our mission is to reimagine medicine to improve and extend people’s lives. We value our people and believe in fostering a collaborative and innovative environment. Join us to be part of a team dedicated to achieving breakthroughs that make a real difference in patients' lives.

    Benefits and Rewards: Explore all the ways we support your growth and well-being in the Novartis Life Handbook: Novartis Benefits & Rewards.

    Join Our Network: If this role isn’t the perfect fit but you want to stay connected for future opportunities, join the Novartis Network: Novartis Talent Network.

    Commitment to Diversity and Inclusion: Novartis is committed to an inclusive work environment and building diverse teams that reflect the communities we serve.

    Accessibility and Accommodation: If you require reasonable accommodation due to a medical condition or disability, please contact us at diversityandincl.india@novartis.com with your request and contact details, including the job requisition number.

    Ready to Create a Brighter Future Together? Learn more about our mission and how we are making an impact: Novartis Strategy.

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