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Global PV Case Manager
Há 1 mês
Job Title: Drug Safety Specialist
Job Description:
Responsibilities:
- Responsible for day-to-day adverse events case management, including case intake and follow-up activities in accordance with Global Pharmacovigilance procedures and country regulations.
- Responsible for the intake of cases received from designated points of contact, vendors, and business partners for individual case safety reports (ICSRs), including tracking and translation to English and forwarding of information to the Data Management Center.
- Performs ICSR acknowledgments and reconciliation activities.
- Responsible for execution of local PV processes and activities in alignment with PV systems and their associated Quality Management System, following department SOPs, company policies and procedures, and country legislation.
- Performs reconciliation activities for PV cases received from local operating units and contractual partners, and processes the reports in accordance with local procedures/PV legislations.
- Provides support for Patient Support Programs (PSP) and/or Market Research vendor(s) related activities, as applicable.
- Files, stores, and archives safety-related and regulatory data and documentation in accordance with department and company policies and local requirements.
- Acts in full compliance with global and local SOPs and reports any deviations or compliance concerns immediately, and assists in preparing necessary corrective actions and preventative actions (CAPAs) locally for non-compliance issues.
- Supports local PV audits and inspections, including readiness activities, and supports other audits/inspections, including the development of CAPAs in response to findings/observations.
- Participates in and supports audits of contractual partners/vendors as necessary. May be trained and assigned responsibility to conduct qualification and ongoing audits of vendors and perform due diligence activities for local country licensing agreements.
- Assists in developing local procedures (in compliance with regional and global standards) for the department, to ensure quality PV data and evaluates processes for potential improvement in efficiency and effectiveness.
- Proactively identifies procedural gaps and challenges and implements solutions in collaboration with all affected stakeholders.
- Supports training of local company staff, distributors, vendors, business partners, including training documentation.
Requirements:
No additional information available.
