Senior Pharmacovigilance Quality Specialist

Job Title: Senior Pharmacovigilance Quality Specialist

Company: A Global Biotechnology Company

Location: Hybrid with 2 days in the office in Maidenhead

Hours: Full-Time

Availability to start: ASAP

Job Scope

Perform quality control (QC) reviews to ensure documents produced by the Safety Surveillance and Aggregate Reports (SSA) team, or their vendors, meet high-quality standards. Support process improvements and contribute to additional SSA functions such as vendor management and SharePoint administration.

Key Responsibilities

• Conduct QC reviews of documents produced by the SSA team, including:
• Verifying source data to ensure all data and methodologies align with original source documents, including cross-checking text against database outputs.
• Performing editorial, technical, and scientific reviews to ensure grammatical accuracy, stylistic consistency, and adherence to relevant style guidelines.
• Documenting findings and providing clear feedback for authors to take appropriate corrective actions. Where necessary, collaborate with authors to review findings, determine next steps, and support development of revised content.
• Review vendor-authored documents and QC activities as part of oversight responsibilities.
• Support the development of training materials for new staff and vendors on quality standards.
• Assist in preparing aggregate report quality trend analyses for team discussions.
• Contribute to the development and maintenance of training materials and job aids.
• Maintain and update SSA templates and QC checklists.
• Support process improvement initiatives related to quality documentation and technical tools, including development of new templates.
• Represent the department in cross-functional improvement initiatives where appropriate.
• Perform administrative tasks such as maintaining tracking spreadsheets and communicating summaries and outcomes to relevant stakeholders.
• Provide support across other SSA functions, which may include vendor management, aggregate reporting processes, SharePoint maintenance, and literature-related activities.
• Train new team members and vendors on SSA quality requirements.

Essential Skills and Qualifications

• Experience: Minimum of 2–3 years’ experience in writing and editing within the pharmaceutical or biotechnology industry.
• Prior experience in pharmacovigilance, medical writing, scientific editing, or publishing is also needed.
• 2+ years experience in quality review, data checking against source material, and editorial oversight (grammar, formatting).
• Experience with safety documents (PSURs, DSURs, PADRs)
• Advanced Microsoft Excel proficiency is non-negotiable (pivot tables, data verification).
• Excellent written English skills, with strong attention to detail and familiarity with medical terminology and the American Medical Association (AMA) Manual of Style.
• Knowledge of pharmacovigilance and drug development, including clinical trial and post-marketing safety regulations.
• Understanding of case processing, expedited reporting requirements, and safety database concepts.
• Ability to interpret, analyse, and clearly present scientific and medical data in both written and verbal formats.
• Strong collaboration skills and ability to work effectively within a team environment.
• Highly organised, with the ability to prioritise tasks independently.
• Proficiency in common data processing and presentation tools (e.g., Excel, PowerPoint, Microsoft Word, Business Objects).
• Education: Bachelor’s degree in a biological or natural science, or a healthcare-related discipline.

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