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Analyst – Patient Oriented Programs

2-5 years
Not Disclosed
10 July 29, 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

Summary

The primary responsibility of this role is to oversee the Patient-Oriented Program (POP), ensuring compliance with applicable processes and quality standards. You will work closely with cross-functional teams to facilitate the successful execution of the POP.

About the Role

Position: Analyst - Patient-Oriented Program

Location: Hyderabad (#LI Hybrid)

Role Overview:

As the Analyst for the Patient-Oriented Program, you will manage the end-to-end POP process in accordance with the Doing Business Ethically (DBE) policy and POP Standard Operating Procedures (SOP). You will coordinate with various stakeholders to ensure the smooth execution of the program and maintain compliance throughout its lifecycle.

Key Responsibilities

  • End-to-End Management: Administer the POP process on behalf of the Business Owner, ensuring adherence to DBE policy and SOPs.
  • Stakeholder Coordination: Collaborate with all POP stakeholders, including POP Champions, Procurement, Legal, Patient Safety, Compliance, and Quality Assurance, to create necessary POP documents.
  • Approval and Compliance: Secure timely approvals for POP conduct and manage compliance checks with External Service Providers (ESP) before initiating fieldwork.
  • Database Management: Enter and track program details in the POPsys database, including FPFC/LPLC dates, Adverse Event Reconciliation (AER), periodic reviews, and program closure activities.
  • Documentation and Issue Management: Maintain comprehensive documentation in the POP repository, address quality issues using the quality issue management tool, and perform root cause analysis and CAPA as needed.
  • Handover and Project Management: Ensure effective handover of responsibilities during role transitions or planned leaves and manage assigned projects efficiently. Seek feedback from stakeholders and implement improvements.

Essential Requirements

  • Experience: 2-5 years of experience in the pharmaceutical industry within Clinical, Pharmacovigilance (PV), Medical/Regulatory Affairs, or a related field.
  • Knowledge: Strong understanding of local regulatory requirements and pharmaceutical industry policies.
  • Communication: Effective communication skills across various audiences, organizational levels, and local and global teams.

Desirable Requirements

  • Education: College/university degree, preferably in security, criminal justice, crisis management, business continuity, or a related field. Advanced degrees (e.g., Master’s or MBA) are highly desirable.

Why Novartis?

At Novartis, our purpose is to reimagine medicine to improve and extend people's lives. Our vision is to be the most valued and trusted medicines company globally, driven by our dedicated associates. Join us to be part of a mission that transforms patient care and advances medical science.

Benefits and Rewards: Explore our benefits and rewards in the Novartis Life Handbook.

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