Senior Global PV Case Processing Lead & SME

CSL Plasma; Wigan; On-site; GBP 50,000 - 70,000; Full time

Job summary

A global biotherapeutics leader is seeking a qualified expert for a role involving oversight of clinical trial and post-marketing pharmacovigilance processes. Responsibilities include managing case handling, ensuring compliance with regulations, and authoring procedural documents. Ideal candidates will have over a decade of experience, particularly in global pharmacovigilance, along with strong leadership capabilities. Join us in making a difference and supporting innovative therapies.

Benefits

Well-being support

Innovative therapies development

Diverse workplace culture

Qualifications

• Minimum of 10 years of experience in Clinical Trial and Post-marketing Pharmacovigilance.
• Proficient knowledge of global and local regulatory rules and regulations.

Responsibilities

• Oversee follow-up activities according to procedural documents.
• Assess and handle literature articles identified by Global Literature Office and Safety Officers.
• Serve as Subject Matter Expert (SME) for case processing-related processes.
• Collaborate with GSPV and external stakeholders to optimize case management processes.
• Maintain tracking tool for new process decisions.
• Support investigation and assessment of ICSR compliance activities.
• Conduct Reg Intelligence assessment for updates impacting case processing.
• Manage audit and inspection readiness including corrective & preventive action.
• Be SME for initiatives or projects in case processing.

Skills

Clinical Trial and Post‑marketing Pharmacovigilance experience

Global pharmacovigilance database knowledge

Experience authoring/updating SOPs, work instructions

Education

BS/BA, RN, Pharmacist or similar

Job description

A global biotherapeutics leader is seeking a qualified expert for a role involving oversight of clinical trial and post-marketing pharmacovigilance processes. Responsibilities include managing case handling, ensuring compliance with regulations, and authoring procedural documents. Ideal candidates will have over a decade of experience, particularly in global pharmacovigilance, along with strong leadership capabilities. Join us in making a difference and supporting innovative therapies.