Global PV Case Processing Leader & Compliance SME

CSL (EMEA); United Kingdom; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading biotherapeutics company is seeking a highly experienced professional to oversee pharmacovigilance processes. The ideal candidate will have a minimum of 10 years of experience in Clinical Trials and Post-marketing Pharmacovigilance, with a strong background in regulatory compliance and case management. Responsibilities include managing procedural documents, collaborating with stakeholders, and ensuring audit readiness. Benefits include prioritization of well-being in a mission-driven organization.

Benefits

Wellness prioritization

Diverse workplace

Innovative therapies development

Qualifications

• Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience.
• Direct experience authoring/updating SOPs and work instructions.

Responsibilities

• Oversee follow-up activities for case management.
• Serve as SME for case processing-related processes.
• Collaborate with stakeholders to optimize case management.

Skills

Clinical Trial experience

Post-marketing Pharmacovigilance experience

Pharmacovigilance database knowledge

Regulatory rules and regulations knowledge

Authoring/Updating SOPs

Education

BS/BA, RN, Pharmacist, or similar

Job description

A leading biotherapeutics company is seeking a highly experienced professional to oversee pharmacovigilance processes. The ideal candidate will have a minimum of 10 years of experience in Clinical Trials and Post-marketing Pharmacovigilance, with a strong background in regulatory compliance and case management. Responsibilities include managing procedural documents, collaborating with stakeholders, and ensuring audit readiness. Benefits include prioritization of well-being in a mission-driven organization.