Viatris
Website:
viatris.com
Job details:
VIATRIS™, is a new kind of healthcare Company, committed to providing access to medicines, advancing sustainable operations developing innovative solutions, and leveraging our collective expertise to improve patient outcomes. Formed in 2020, through the combination of Mylan and Up-John-Pfizer, Viatris bring together best in class scientific, Manufacturing and distribution expertise with proven regulatory, Medical and commercial capabilities to deliver quality medicines to patients when and where they need it.
KEY RESPONSIBILITIES:
• Assist in retrospective quality oversight of global individual case safety reports (ICSRs) in the global drug safety database to ensure quality and consistency in line with Viatris conventions.
• Author and revise Viatris global procedural documents and data entry conventions to ensure compliance with PV regulations and the enhancement of Viatris processes.
• Vendor management – provide regular feedback to vendors to improve case quality.
• Develop and maintain global training materials, provide regular training and ensure appropriate staff are trained in activities related to ICSR Handling.
• Assist in answering PV operations related queries received from vendors, global sites and affiliates safety representatives.
• Review changes to legislation concerning pharmacovigilance, clinical and medical devices. Ensure that the Operations team are aware of these changes and update processes and materials accordingly.
• Manage Global Pharmacovigilance Operations CAPAs to ensure CAPAs identified and closed within the agreed timelines.
• Assist Global PV Operations Leads with global PSRM internal audits and Regulatory inspections (preparation, documents requests and CAPA management).
• Devise and implement process improvement measures for global PV Operations processes.
• Manage individual projects as assigned within the PV Operations team, including business integration projects and database enhancement projects.
QUALIFICATION AND EXPERIENCE:
• Minimum 3-4 years Pharmacovigilance experience (ICSR Management & Quality review experience desirable).
•Knowledge of post marketing and drug development, including knowledge of applicable post marketing safety regulations.
• Strong organizational skills, including the ability to prioritize independently with minimal supervision.
• Good knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word).
• Good time management skills with an ability to prioritize and plan the work for a productive and effective outcome.
• Good presentation and communication skills
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