Analyst, Patient Oriented program

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

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.

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.