Senior PV Scientist, Quality Document Associate
Senior PV Scientist, Quality Document Associate
Join a dynamic team where your quality review expertise ensures the safety and compliance of vital pharmaceutical documents. This Senior PV Scientist, Quality Document Associate role offers a unique opportunity to make a meaningful impact within the pharmaceutical industry, supporting life-changing treatments and advancing medical safety standards.
Overview
Based in Maidenhead, UK, this role is a pivotal part of our safety and quality assurance team. You'll be responsible for meticulously reviewing and editing safety documents such as PSURs and DSURs, ensuring their accuracy, clarity, and compliance. Collaborate closely with PV scientists and report authors to uphold the highest standards of data integrity and editorial quality, contributing directly to patient safety and regulatory compliance.
Key Responsibilities
- 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.
Must-Have Skills and Experience
- Minimum of 2 years' experience in quality review, data verification, and editorial oversight.
- Proven experience reviewing safety documents such as PSURs and DSURs (excluding case processing).
- Advanced proficiency in Microsoft Excel, including pivot tables and data verification.
- Strong background in PV safety or Medical Writing Quality Control (QC).
- Transferable skills in data checking and editorial review, with flexibility to learn PV-specific processes.
Nice-to-Have Skills
- Experience with safety documents like PADRs.
- Knowledge of PV safety or Medical Writing beyond QC.
- Ability to work flexibly on-site or remotely.
This 12-month contract offers a collaborative, supportive team environment. Be part of an organization committed to excellence in global healthcare.
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