Analyst – Patient Oriented Programs

2-5 years

Not Disclosed

Hyderabad

10 Sept. 23, 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

The primary responsibility of this role is to manage the Patient-Oriented Program (POP), ensuring compliance with applicable processes and quality standards throughout the program's lifecycle. This position involves collaboration with cross-functional teams to successfully execute the POP.

About the Role

Position: Analyst, Patient-Oriented Program
Location: Hyderabad (#LI Hybrid)

Key Responsibilities:

Oversee the end-to-end POP process on behalf of the Business Owner, adhering to the Doing Business Ethically (DBE) policy and POP Standard Operating Procedures (SOP).
Coordinate with all POP stakeholders, including the POP Champion, Procurement, Legal, Patient Safety, Compliance, and Quality Assurance, to create necessary POP documentation.
Obtain timely approvals for POP execution and manage compliance checks for External Service Providers (ESP) prior to fieldwork initiation.
Enter program details into the POPsys database, tracking all required activities (e.g., First Participant First Contact, Last Participant Last Contact, Adverse Event Reconciliation, Periodic Reviews, and closure) to ensure no monitoring gaps exist before program closure.
Maintain thorough documentation of all POP-related activities in the POP repository, ensuring quality issues are documented using the Quality Issue (QI) management tool. Conduct investigations, root cause analyses, risk assessments, and implement Corrective and Preventive Actions (CAPA).
Ensure effective handover of responsibilities during role transitions or planned leaves, collaborating with the POP Champion.
Manage all assigned projects effectively and escalate any findings in a timely manner. Continuously seek feedback from stakeholders and implement improvements based on their suggestions.

Essential Requirements:

2-5 years of experience in the pharmaceutical industry, particularly in Clinical, Pharmacovigilance (PV), Medical/Regulatory Affairs, or relevant compliance areas.
Strong understanding of local regulatory requirements and policies within the pharmaceutical industry.
Excellent communication skills, capable of engaging effectively with diverse audiences and teams at local and global levels.

Desirable Requirements:

A degree in a relevant field such as security, criminal justice, crisis management, or business continuity; an advanced degree (e.g., Master’s or MBA) is highly desirable.

Why Novartis?

Our mission is to reimagine medicine to improve and extend lives. We aim to be the most valued and trusted medicines company globally, driven by our associates. Join us in this important mission!

Benefits and Rewards

For detailed information on our benefits and rewards, refer to the Novartis Life Handbook here.

Join Our Novartis Network

If this role isn't a perfect match for you but you'd like to stay informed about future opportunities, join the Novartis Network here.

At Novartis, we believe that achieving breakthroughs in healthcare requires a collaborative community of passionate individuals. Together, we can create a brighter future for patients and their families.

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Analyst – Patient Oriented Programs

Job Description

Summary

About the Role

Key Responsibilities:

Essential Requirements:

Desirable Requirements:

Why Novartis?

Benefits and Rewards

Join Our Novartis Network

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