Senior Clinical Trial Case Manager
CSL • Maidenhead, United Kingdom
Role Description
Responsibilities:• Leads or plays a key role in cross-functional teams for the review of safety data or safety-related reports
• Mentors and trains newer members of the functional area
• Ensures functions to comply with national and international regulations, such as GxP guidelines and/or any other relevant international and national legislation(s), regulations(s), and guidance(s) as well as company policies and procedures in area of responsibility
• Ensures direct reports to support and ensure QPPV’s oversight on the company’s Pharmacovigilance system, and identify, implement and monitor KPIs/KQIs across the company and manages cross functional CAPAs and other improvement activities on behalf of the QPPV.
• Performs impact assessment of evolving pharmacovigilance legislations and propose or provide strategic direction for implementation of required changes to the global PV system. This may involve cross-functional approaches, including multiple interface functions.
• Su...
• Mentors and trains newer members of the functional area
• Ensures functions to comply with national and international regulations, such as GxP guidelines and/or any other relevant international and national legislation(s), regulations(s), and guidance(s) as well as company policies and procedures in area of responsibility
• Ensures direct reports to support and ensure QPPV’s oversight on the company’s Pharmacovigilance system, and identify, implement and monitor KPIs/KQIs across the company and manages cross functional CAPAs and other improvement activities on behalf of the QPPV.
• Performs impact assessment of evolving pharmacovigilance legislations and propose or provide strategic direction for implementation of required changes to the global PV system. This may involve cross-functional approaches, including multiple interface functions.
• Su...