Összegzés
About the Role
Key Responsibilities:
Responsible for the design of operations, planning and conduct of PSP, ensuring resource and time allocation for completing all activities:
• Co-ordinate with all PSP stakeholders (POP Champion/ Medical/ Procurement/ Legal/ Patient Safety/ Compliance/ Innovation), as appropriate.
• Regularly interact with the POP Champion and the Pharmacovigilance Responsible (PVR) in order to discuss PSP and ESP performance and compliance, and collaborate with them to actively follow-up on cases of non-compliance, including late AE reporting, and to ensure appropriate action and risk mitigation (deviations and CAPAs)
• Ensure proper handover of activities when leaving the role/organization/planned leaves and liaise with POP Champion as required
• Responsible for obtaining the appropriate approvals (compliance and POPsys) for conduct of PSP in a timely manner
- Responsible for the overall management of the External Service Provider(s) (ESPs)/Healthcare Professional (HCP), being the main point of contact and ensuring the following activities are completed prior to the beginning of ESP services
- conduct of POP Supplier Quality Assessment (SQA) and other supplier qualifications (Information Security and Risk Management (ISRM)/Third-Party Risk Management Assessment (TPRM), Anti-Bribery), as applicable
- contract execution, including Pharmacovigilance and data privacy language, and
- Ensure ESP AE training completion
- Ensure associate(s) complete PSP related mandatory training
- Reconcile the enrollment forms and relevant evidences against refunded amounts on a regular basis to ensure that the right support is reaching to right patients
- Maintain and file relevant key documents including g-folder and hardcopy files with each event master binder (e.g. approval form, minutes, signed contract, vendor QC, etc.)
- Ensure quality check on all regular reports/equivalent means from vendor
• In collaboration with the Source Data Verification Responsible (SDVR), responsible for identifying source documents and ensuring they are clearly communicated to the ESP/HCP and local POP stakeholders
• Enter program details in the POPsys database throughout the conduct of the PSP
• Ensure required data is obtained to conduct monitoring activities (Adverse Event Reconciliation (AER) and Source Data Verification (SDV))
• Keep track of all required activities (FPFC/LPLC dates, AER, SDV, closure, etc.) related to PSP conduct and ensure completion before program closure in database
• Develop program materials for PSP based on approved scheme and ensure them in compliance with company guidance.
• Manage appropriate budget related to PSP(Patient Support Program) operations
• Ensure compliance with all local laws and regulations
• Support during internal/external audits and inspections as needed
• Execute financial and legal activities (development of contract, review process via CLM, payment via SRM) in accordance with internal procedure.
• Track and share program status with internal stakeholders Resolve any issue on PSP through timely notice internally and externally
Essential Requirements:
• Relevant experience with Customer service
• Cross-functional collaboration experience
• Adaptability to new technology and challenge-oriented with passion and confidence
• Solid understanding of patient and hospital environment
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 an Equal Opportunity Employer and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
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
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
