job title: analyst-patient oriented program(novartis)

Key Responsibilities:

• Responsible for the design, planning and conduct of the POP, ensuring resource and time allocation for completing all activities:

  • Coordinate with all POP stakeholders (POP Champion/ Procurement/ Legal/ Patient Safety/ Compliance), as appropriate;

  • Responsible for obtaining the appropriate approvals (compliance and POPSys) for conduct of POP in a timely manner;

  • Responsible for the overall management of the External Service Provider (ESP)/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 Assessment (TPRM), Anti-Bribery), as applicable;

    • contract execution, including Pharmacovigilance (PV) and Data Privacy (DP) language, and

    • ESP AE training;

  • 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 POP;

  • 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, Periodic Reviews, closure, etc.) related to POP conduct and ensure completion before program closure in database;

• Regularly interact with the POP Champion and the Pharmacovigilance Responsible (PVR) in order to discuss POP 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 compliance with all local laws and regulations;

• Support during internal/external audits and inspections as needed;

• Ensure proper handover of activities when leaving the role/organization/planned leaves and liaise with POP Champion as required.

Essential Requirements:

• Preferably, relevant experience in the pharmaceutical industry within medical affairs, compliance or commercial

• Good understanding of relevant local laws and regulations and Novartis compliance, marketing, data privacy and anti-bribery guidelines

• Ability to communicate effectively across different audiences, organizational levels and local and global teams.

• Excellent written and verbal skills. Strong interpersonal skills.

• Good English language skills

• Ability to provide efficient, timely, reliable, and courteous service to customers. Ability to effectively present information