Effective Medical Ltd
Quality Controller
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Quality Controller / QC Specialist
Position: Permanent (Full-Time or Part-Time) / Contract
Location: Home working (UK / Remote)
Salary & Benefits:
- Competitive salary / attractive contractor rates
- Annual performance bonus
- Free comprehensive private healthcare
- Company pension scheme
- 25 days’ holiday + bank holidays (pro-rata)
- Paid charity days
- Training & personal development support
- 100% remote working setup
Role Overview The Quality Controller will be responsible for conducting rigorous quality control and data verification reviews on pharmacovigilance, regulatory, and clinical documentation. You will ensure 100% data integrity, consistency against source tables/listings, and strict compliance with style guides and regulatory guidelines.
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Key Responsibilities
- Conduct rigorous 100% data verification of safety reports (PSURs/PBRERs, DSURs, Safety Reviews, RMPs) and clinical documents (CSRs, CSPs, IBs) against source data (TLFs, safety databases, statistical outputs).
- Check consistency across text, in-text tables, appendices, abbreviations, and literature citations.
- Verify document formatting, styles, and template adherence in line with client SOPs and regulatory standards.
- Annotate and log discrepancies clearly using track changes, comment logs, and Adobe Acrobat markup tools.
- Collaborate with medical writers and project leads to resolve findings efficiently ahead of submission deadlines.
- Ensure documents meet audit readiness and ICH-GCP / GVP compliance.
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Required Experience & Skills
- 1–3+ years of dedicated QC or editorial experience with clinical, regulatory, or PV documents in a pharma, CRO, or life sciences agency environment.
- Exceptional numerical accuracy and meticulous attention to detail.
- Understanding of safety reports (PSURs, DSURs), clinical trial structures, and source data (TLFs).
- Advanced proficiency in MS Word (styles, formatting, tracking) and Adobe Acrobat.
- Experience with electronic document management systems (e.g., CARA) and virtual environments is beneficial.
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