Location: Hyderabad, India (Hybrid)
Division: Operations | Business Unit: CTS
Company: Novartis Healthcare Private Limited
Job Type: Full-time | Employment Type: Regular
At Novartis, we are dedicated to reimagining medicine to improve and extend people’s lives. Our vision is to become the most valued and trusted medicines company in the world, and this mission starts with the people we hire. We are currently seeking an Analyst for Patient-Oriented Programs (POP) to ensure compliance and successful execution of POP activities.
As an Analyst in Patient-Oriented Programs (POP), you will manage end-to-end activities for POP, ensuring all activities are conducted in compliance with applicable processes and quality standards. This role will involve liaising with cross-functional teams to drive the successful execution of the program.
End-to-End Process Management: Administer the entire POP process in compliance with Novartis' Doing Business Ethically (DBE) policy and POP Standard Operating Procedures (SOPs).
Stakeholder Coordination: Collaborate with various teams including POP Champions, Procurement, Legal, Patient Safety, Compliance, and Quality Assurance to create and manage POP documents.
Approval and Compliance: Ensure timely approvals for conducting POP and manage compliance checks for External Service Providers (ESP) before fieldwork initiation.
Data Management: Track and enter program details in the POPsys database, maintaining accurate records of all activities (e.g., FPFC/LPLC dates, AE reconciliation, periodic reviews, and program closure).
Documentation and Reporting: Maintain thorough documentation for all POP activities in the POP repository. Use the Quality Issue (QI) management tool to document and resolve quality issues, conduct investigations, root cause analysis, and implement corrective and preventive actions (CAPA).
Handover and Project Management: Ensure smooth handover of activities in case of role transitions or planned leaves, and escalate any findings in a timely manner. Continuously improve processes based on stakeholder feedback.
Experience: 2-5 years of experience in the pharmaceutical industry, particularly in Clinical, Pharmacovigilance (PV), Medical/Regulatory Affairs, or pharma compliance/commercial frameworks.
Regulatory Knowledge: Good understanding of local regulatory requirements and policies surrounding the pharmaceutical industry.
Communication Skills: Ability to communicate effectively with various audiences, including cross-functional teams at local and global levels.
At Novartis, our associates are the heart of our success. We are committed to creating a work environment that fosters collaboration, innovation, and growth. As part of our team, you will play a key role in shaping the future of healthcare and driving breakthroughs that improve patients' lives.
Novartis is committed to providing reasonable accommodations to individuals with disabilities. If you require assistance during the recruitment process or to perform essential job functions, please contact diversityandincl.india@novartis.com for further support.
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