Global PV Case Oversight Lead – Medical Evaluation

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

Job summary

A global biotherapeutics leader is seeking a Medical Evaluation & Case Processing Oversight Lead in Maidenhead, UK. This role involves overseeing single case processing in pharmacovigilance and ensuring regulatory compliance. Ideal candidates will have over 10 years of experience in Clinical Trials and Pharmacovigilance, with at least 5 years in leadership. Successful candidates will drive innovative solutions in data management and regulatory compliance while preparing for inspections. Join a team committed to developing therapies that make a meaningful difference worldwide.

Qualifications

• Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience with 5 years of managerial/leadership experience.
• Proficient knowledge of global and local regulatory rules and regulations.

Responsibilities

• Oversee all areas of single case processing in pharmacovigilance.
• Ensure vendor compliance with regulatory guidelines and SOPs.
• Prepare for internal and external inspections and lead transformation initiatives.

Skills

Clinical Trial experience

Pharmacovigilance experience

Regulatory knowledge

Leadership experience

Education

BS/BA, RN, Pharmacist, or similar

Job description

A global biotherapeutics leader is seeking a Medical Evaluation & Case Processing Oversight Lead in Maidenhead, UK. This role involves overseeing single case processing in pharmacovigilance and ensuring regulatory compliance. Ideal candidates will have over 10 years of experience in Clinical Trials and Pharmacovigilance, with at least 5 years in leadership. Successful candidates will drive innovative solutions in data management and regulatory compliance while preparing for inspections. Join a team committed to developing therapies that make a meaningful difference worldwide.