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Analyst – Patient Oriented Programs

2+ years
Not Disclosed
10 Oct. 30, 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

Summary

In this role, you will manage the Patient Oriented Program (POP), ensuring compliance with all applicable processes and quality standards. You will liaise with cross-functional teams to facilitate the successful execution of POP activities.

About the Role

Location: Hyderabad | Work Model: Hybrid

Key Responsibilities

  • Administer the end-to-end POP process on behalf of the Business Owner (BO) in line with the Doing Business Ethically (DBE) policy and POP Standard Operating Procedures (SOP).
  • Coordinate with all POP stakeholders, including Procurement, Legal, Patient Safety, Compliance, and Quality Assurance, to create and maintain POP documentation.
  • Obtain necessary approvals for the conduct of POP in a timely manner, and manage compliance checks for External Service Providers (ESP) before fieldwork initiation.
  • Enter program details into the POPsys database and track all related activities, ensuring no monitoring gaps prior to program closure.
  • Maintain thorough documentation of all POP-related activities and manage identified quality issues using the quality issue (QI) management tool, including root cause analysis and corrective actions.
  • Ensure effective handover of responsibilities when leaving the role or during planned leaves, maintaining communication with the POP Champion.
  • Manage all assigned projects effectively and escalate any findings in a timely manner, while seeking feedback from stakeholders to drive continuous improvement.

Essential Requirements

  • 2-5 years of experience in the pharmaceutical industry, particularly in Clinical, Pharmacovigilance (PV), or Medical/Regulatory Affairs, or relevant experience in pharma compliance.
  • Strong understanding of local regulatory requirements and policies related to the pharmaceutical industry.
  • Excellent communication skills across different audiences and organizational levels.

Desirable Requirements

  • College/university degree in security, criminal justice, crisis management, business continuity, or a related field. An advanced degree (e.g., Master’s or MBA) is highly desirable.

Why Novartis?

Our purpose is to reimagine medicine to improve and extend people’s lives. Our vision is to become the most valued and trusted medicines company in the world. Join us in this mission and be part of a team that drives innovation every day!

Benefits and Rewards

Find out more about our benefits and rewards in the Novartis Life Handbook: Benefits & Rewards

Join Our Network

If this role isn’t the right fit but you wish to stay connected with Novartis, join our talent community: Novartis Network

Accessibility and Accommodation

Novartis is committed to providing reasonable accommodations for individuals with disabilities. For assistance during the recruitment process, please contact diversityandincl.india@novartis.com and include the job requisition number.

Commitment to Diversity

Novartis is dedicated to fostering an inclusive work environment with diverse teams that reflect the communities we serve.