Summary
The primary responsibility of this role is to manage patient oriented program (POP). Responsible to ensure compliance in POP end to end activities as per the applicable process and quality standards. Liaison with the cross functional team for successful execution of POP.
About The Role
Analyst Patient-Oriented Program
Location Hyderabad Hybrid
About The Role:
The primary responsibility of this role is to manage patient oriented program (POP). Responsible to ensure compliance in POP end to end activities as per the applicable process and quality standards. Liaison with the cross functional team for successful execution of POP.
Key Responsibilities:
- 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.
Essential Requirements:
- Preferrable experience with 2- 5 years experience in the pharmaceutical industry within Clinical, Pharmacovigilance (PV), Medical/regulatory Affairs, or relevant experience in pharma compliance or commercial framework.
- Good understanding of local regulatory requirements and applicable policies surrounding pharmaceutical industry
- Ability to communicate effectively across different audiences, organizational levels and local and global teams.
Desirable Requirements:
- College/university degree, preferably in security, criminal justice, crisis management, business continuity or other related field. Advanced degree is highly desirable (e.g., Master's degree or MBA).
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
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
Join our Novartis Network: Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
