Analyst - Patient-Oriented Program

Key Responsibilities

• End-to-End Management:

  Administer the POP process on behalf of the Business Owner, ensuring adherence to DBE policy and SOPs.

• Stakeholder Coordination:

  Collaborate with all POP stakeholders, including POP Champions, Procurement, Legal, Patient Safety, Compliance, and Quality Assurance, to create necessary POP documents.

• Approval and Compliance:

  Secure timely approvals for POP conduct and manage compliance checks with External Service Providers (ESP) before initiating fieldwork.

• Database Management:

  Enter and track program details in the POPsys database, including FPFC/LPLC dates, Adverse Event Reconciliation (AER), periodic reviews, and program closure activities.

• Documentation and Issue Management:

  Maintain comprehensive documentation in the POP repository, address quality issues using the quality issue management tool, and perform root cause analysis and CAPA as needed.

• Handover and Project Management:

  Ensure effective handover of responsibilities during role transitions or planned leaves and manage assigned projects efficiently. Seek feedback from stakeholders and implement improvements.

Essential Requirements

• Experience:

  2-5 years of experience in the pharmaceutical industry within Clinical, Pharmacovigilance (PV), Medical/Regulatory Affairs, or a related field.

• Knowledge:

  Strong understanding of local regulatory requirements and pharmaceutical industry policies.

• Communication:

  Effective communication skills across various audiences, organizational levels, and local and global teams.

Desirable Requirements

• Education:

  College/university degree, preferably in security, criminal justice, crisis management, business continuity, or a related field. Advanced degrees (e.g., Master s or MBA) are highly desirable.