Senior PV Quality Documents Lead (Remote-Eligible)

Planet Pharma; Maidenhead; Vor Ort; GBP 40.000 - 60.000; Vollzeit

Zusammenfassung

Planet Pharma in Maidenhead, UK, seeks a Senior PV Scientist, Quality Document Associate on a 12-month contract. You will review and edit safety documents (PSURs/DSURs) for accuracy, clarity and regulatory compliance, working with PV scientists and report authors on-site.

You should have at least 2 years in quality review/data verification, strong Excel skills, and a background in PV safety or Medical Writing QC. This role offers collaborative teamwork and opportunities to impact patient safety.

Qualifikationen

• Minimum of 2 years’ experience in quality review and data verification.
• Experience reviewing PSURs and DSURs (not case processing).
• Advanced Excel skills, including pivot tables and data verification.
• Background in PV safety or Medical Writing QC.
• Strong data checking and editorial review abilities with PV process flexibility.

Aufgaben

• Perform quality reviews of safety documents, including PSURs and DSURs, verifying data against source materials.
• Conduct data checking and validation, with a focus on ensuring accuracy and consistency across documents.
• Provide editorial oversight, including grammar, formatting, and document presentation.
• Collaborate with PV scientists and aggregate report authors to maintain high-quality documentation.
• Support cross-functional teams with quality assurance activities and process improvements.
• Contribute to the preparation of documentation for regulatory submission, ensuring deadlines are met.

Kenntnisse

Quality review

Data verification

Editorial review

PV safety

Medical writing QC

Tools

Microsoft Excel

Jobbeschreibung

Planet Pharma in Maidenhead, UK, seeks a Senior PV Scientist, Quality Document Associate on a 12-month contract. You will review and edit safety documents (PSURs/DSURs) for accuracy, clarity and regulatory compliance, working with PV scientists and report authors on-site.

You should have at least 2 years in quality review/data verification, strong Excel skills, and a background in PV safety or Medical Writing QC. This role offers collaborative teamwork and opportunities to impact patient safety.