SENIOR PV SCIENTIST, QUALITY DOCUMENT ASSOCIATE

Planet Pharma

Maidenhead

On-site

GBP 40,000 - 60,000

Full time

16 hours ago
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Job summary

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.

Qualifications

  • 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.

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.

Skills

Quality review
Data verification
Editorial review
PV safety
Medical writing QC

Tools

Microsoft Excel

Job description

Senior PV Scientist, Quality Document Associate

Location: Maidenhead, Berkshire

Category: Pharmacovigilance

Salary: Apply for details

Country: United Kingdom

Employment: Contract

Worksite: On-Site

Job Description

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.

Equal Opportunity Employer

We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us(opens in new tab) directly so that we can explore the appropriate arrangements.

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