Senior PV Case Manager — Global Trials & Compliance

CSL; Maidenhead; Vor Ort; GBP 65.000 - 90.000; Vollzeit

Zusammenfassung

CSL is seeking a senior Pharmacovigilance expert to lead case management activities for clinical trials in a multinational setting. You will ensure compliance with GxP guidelines, local and international regulations, and deliver safety data analyses and KPI reporting.

You will collaborate with cross-functional teams, support PV inspections, and manage external vendors to maintain GSPV standards and timely reporting of ICSR cases in line with regulatory requirements.

Qualifikationen

• 7+ years of Pharmacovigilance experience in a multinational pharma environment.
• Expert knowledge of local and international regulations and PV processes.
• Experience with regulatory inspections and complex data sets.
• Experience managing CAPA and SOP development projects.
• Experience with relevant software applications.

Aufgaben

• Acts as Case Management SME in cross-functional teams for assigned trials.
• Manages case management activities to ensure compliance with GxP and regulations.
• Oversees safety data processing and timely regulatory reporting.
• Supports PV inspections and audits as required.
• Liaises with external vendors to ensure GSPV standards.

Kenntnisse

Pharmacovigilance

Regulatory inspections

CAPA & SOPs

Data analysis

GxP compliance

Vendor management

Ausbildung

Bachelor's degree in life sciences

Master's/PhD preferred

Tools

PV software

Jobbeschreibung

CSL is seeking a senior Pharmacovigilance expert to lead case management activities for clinical trials in a multinational setting. You will ensure compliance with GxP guidelines, local and international regulations, and deliver safety data analyses and KPI reporting.

You will collaborate with cross-functional teams, support PV inspections, and manage external vendors to maintain GSPV standards and timely reporting of ICSR cases in line with regulatory requirements.