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Job Description
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.