Senior PV & Regulatory Platform Lead

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

Job summary

A global biotherapeutics leader in Maidenhead seeks a Senior Manager PV & Reg Platform responsible for providing operational support for pharmacovigilance and regulatory activities. The role includes system configuration, user engagement, and issue tracking, ensuring timely delivery of services. Candidates should have a Bachelor's degree in Life Sciences and at least 7 years of relevant experience, including Management and Project Management expertise. Competitive benefits offered.

Qualifications

• 7 years of experience in pharmacovigilance or regulatory systems support.
• Strong attention to detail and ability to manage multiple tasks across teams.
• Experience supporting validation and compliance documentation.

Responsibilities

• Support day-to-day operations of PV and regulatory platforms.
• Help document requirements and support user acceptance testing.
• Coordinate with IT and business stakeholders to resolve platform issues.

Skills

Program Management

FDA Regulations

Management Experience

Facilities Management

Clinical Development

Data Management

Quality Systems

Project Management

Research & Development

GLP

Budgeting

Leadership Experience

Education

Bachelor’s degree in Life Sciences, Health Informatics or related field

Tools

PV databases

Argus

Veeva RIM

Job description

A global biotherapeutics leader in Maidenhead seeks a Senior Manager PV & Reg Platform responsible for providing operational support for pharmacovigilance and regulatory activities. The role includes system configuration, user engagement, and issue tracking, ensuring timely delivery of services. Candidates should have a Bachelor's degree in Life Sciences and at least 7 years of relevant experience, including Management and Project Management expertise. Competitive benefits offered.