Summary
• Coordinate with all POP stakeholders (POP Champion/ Procurement/ Legal/ Patient Safety/ Compliance/Quality Assurance) and create POP documents.
• Responsible for obtaining the necessary approvals for conduct of POP in a timely manner.
• Responsible for the overall management of the External Service Providers (ESP) compliance check prior to fieldwork initiation.
• Enter program details in the POPsys database throughout the conduct of the POP.
• Keep track of all required activities (First Participant First Contact (FPFC)/Last Participant Last Contact (LPLC) dates, Adverse Event Reconciliation (AER), Periodic Reviews, closure, etc.) related to POP conduct and ensure no monitoring gaps before program closure in POPsys.
• Maintain documentation for all POP related activities in POP repository.
• Ensure identified quality issues are well documented in quality issue (QI) management tool. Create issue record and perform proper investigation, root cause analysis followed by risk assessment and corrective and preventive actions (CAPA).
• Ensure proper handover of activities when leaving the role/organization/planned leaves and liaise with POP Champion.
• Effective management of all projects assigned, and timely escalation of findings related to projects.
• Seek constant feedback from stakeholders and improve on suggestions put forth.
Compliance activities:
• Comply with global and local regulations for successful completion of POP activity.
• Ensure completeness of ESP onboarding and compliance (SQA, EPRM, PV provisions, POP AE trainings etc.).
• Follow Integrity & Compliance policies of the organization such as Code of Conduct, Corporate Citizenship, Conflict of interest, Doing Business Ethically and other related organizational policies.
• Support during internal/external audits and inspections as needed.
About the Role
Location – Hyderabad #LI Hybrid
Major accountabilities:
- Administer end to end POP process on behalf of Business Owner (BO) in accordance with Doing Business Ethically (DBE) policy and POP Standard Operating Procedures (SOP).
- Coordinate with all POP stakeholders (POP Champion/ Procurement/ Legal/ Patient Safety/ Compliance/Quality Assurance) and create POP documents.
- Responsible for obtaining the necessary approvals for conduct of POP in a timely manner. Responsible for the overall management of the External Service Providers (ESP) compliance check prior to fieldwork initiation.
- Enter program details in the POPsys database throughout the conduct of the POP.
- Keep track of all required activities (First Participant First Contact (FPFC)/Last Participant Last Contact (LPLC) dates, Adverse Event Reconciliation (AER), Periodic Reviews, closure, etc.) related to POP conduct and ensure no monitoring gaps before program closure in POPsys.
- Maintain documentation for all POP related activities in POP repository. Ensure identified quality issues are well documented in quality issue (QI) management tool. Create issue record and perform proper investigation, root cause analysis followed by risk assessment and corrective and preventive actions (CAPA)
- Ensure proper handover of activities when leaving the role/organization/planned leaves and liaise with POP Champion.
- Effective management of all projects assigned, and timely escalation of findings related to projects.
- Seek constant feedback from stakeholders and improve on suggestions put forth.
Compliance activities:
- Comply with global and local regulations for successful completion of POP activity.
- Ensure completeness of ESP onboarding and compliance (SQA, EPRM, PV provisions, POP AE trainings etc.).
- Follow Integrity & Compliance policies of the organization such as Code of Conduct, Corporate Citizenship, Conflict of interest, Doing Business Ethically and other related organizational policies.
- Support during internal/external audits and inspections as needed.
Key performance indicators (KPIs):
- 100% maintenance of POP and ESP Key performance indicators
- 100% Documentation completeness related to POP.
- Internal stakeholder feedback.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
Read our handbook (PDF 30 MB)
VIDEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
