The Functional Quality Specialist I will ensure high-quality service delivery to internal and external clients while adhering to safety regulations, including the Health and Safety at Work Act 1974, COSHH Regulations 1989, and EC Directives 1992/3. The role involves quality review, compliance monitoring, and process improvement in pharmacovigilance and safety reporting.
Key Responsibilities
- Conduct quality reviews of assigned cases and compile quality metrics.
- Assist in client quality reviews and Corrective and Preventive Actions (CAPA).
- Review safety reports for regulatory submissions (e.g., PSURs, PADERs, Clinical Study Reports).
- Manage expedited adverse event reports, product complaints, and medical information queries.
- Support audit readiness and regulatory inspections.
- Develop Quality Management Plans and track training schedules for new hires.
- Analyze data to identify process improvements and ensure compliance with GCP, GVP, and ICH guidelines.
- Handle medical information queries via phone, email, or fax.
- Guide safety associates in call intake and documentation.
Qualifications & Experience
Minimum Required:
- Education: Bachelor’s/Master’s/PhD in Medicine, Pharmacy, Life Sciences, Nursing, or related fields.
- Experience: 2+ years in pharmaceutical/biotech/CRO industry, with exposure to Pharmacovigilance, Safety Writing, or Quality Review.
- Knowledge:
- Medical & drug terminology
- GCP, GVP, ICH Guidelines
- EU & FDA regulatory requirements
- Technical Skills: Proficiency in Microsoft Office.
Preferred Qualifications:
- Experience in quality metrics & trend analysis.
- Knowledge of Medical Device Reporting (MDR).
- Experience in CAPA management.
Work Environment
- Hybrid/Remote options available.
- 10% travel may be required.
How to Apply
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