Senior Global PV Case Processing Lead & SME

CSL Plasma; Maidenhead; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading biotherapeutics company is seeking an experienced professional to oversee case management and regulatory reporting requirements. The ideal candidate will have over 10 years of experience in Clinical Trials and Pharmacovigilance, alongside a strong knowledge of regulatory rules. This role offers a chance to contribute to the improvement of case management processes and ensure compliance within a dynamic team environment.

Benefits

Well-being support

Innovative work environment

Qualifications

• Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance experience.
• Proficient knowledge of global and local regulatory rules and regulations.
• Direct experience authoring/updating Standard Operating Procedures (SOPs) and work instructions.

Responsibilities

• Oversee follow-up activities in accordance with procedural documents.
• Serve as case processing Subject Matter Expert for procedural documents.
• Collaborate with stakeholders to optimize case management processes.
• Ensure audit and inspection readiness including CAPA management.

Skills

Clinical Trial experience

Post-marketing Pharmacovigilance experience

Knowledge of regulatory rules

Experience authoring/updating SOPs

Education

BS/BA, RN, Pharmacist or similar

Job description

A leading biotherapeutics company is seeking an experienced professional to oversee case management and regulatory reporting requirements. The ideal candidate will have over 10 years of experience in Clinical Trials and Pharmacovigilance, alongside a strong knowledge of regulatory rules. This role offers a chance to contribute to the improvement of case management processes and ensure compliance within a dynamic team environment.