Functional Quality Specialist I – Clinical Quality Oversight
Location: Pune
Category: Clinical
Job ID: 255409
Position Overview
The Functional Quality Specialist I is responsible for ensuring consistent delivery of high-quality, compliant, and cost-effective services for internal and external clients. This role supports end-to-end quality oversight within pharmacovigilance and clinical operations, ensuring adherence to regulatory requirements and organizational standards including the Health and Safety at Work Act 1974, COSHH regulations, and EC directives as outlined in the company’s Health and Safety Manual.
The position requires strong analytical capability, attention to detail, and deep understanding of safety operations and quality review processes.
Key Responsibilities
Quality Review and Compliance
Conduct quality reviews of assigned safety cases and audit samples.
Support the compilation of quality metrics, trend analysis, and periodic client quality reviews.
Assist in the development, execution, and documentation of Corrective and Preventive Actions (CAPA).
Ensure CAPA outcomes are implemented effectively and recorded in collaboration with project managers.
Perform ongoing reviews of safety reports and regulatory documents including IND Annual Reports, PSURs, PADERs, Clinical Study Reports, Core Data Sheets, USPI, SPCs, and Med Guides.
Safety Operations Support
Contribute to functional quality processes across clinical trials and post-marketing settings.
Review expeditable adverse events, product quality complaints, and medical information for regulatory accuracy and timely submission.
Support audit-readiness activities through process reviews, monitoring, and documentation.
Training and Process Improvement
Assist with designing, scheduling, and tracking training programs for new and existing team members.
Create and maintain training materials aligned with updated procedures and systems.
Participate in quality forums to discuss errors, share insights, and recommend process improvements.
Regulatory and Client Support
Prepare documentation and support project teams during client audits and regulatory inspections.
Assist in developing Quality Management Plans and ensuring compliance with sponsor requirements.
Coordinate communication between internal teams and sponsors during quality or inspection-related activities.
Medical Information and Call Review
Review medical information queries, product quality complaints, and general inquiries received via phone, email, or fax.
Ensure accurate documentation and appropriate response in accordance with sponsor procedures.
Guide safety associates on call-handling standards where required.
Data Review and Reporting
Perform and review analytical assessments to propose strategies for process excellence.
Support tracking, reconciliation, and QC of diverse operational data sources.
Review safety reports intended for global regulatory submissions including periodic and cumulative reports.
Other Responsibilities
Provide operational support across quality and safety functions as assigned.
Participate in continuous process review to support quality enhancement initiatives.
Qualifications (Minimum Required)
Bachelor’s, Master’s, or PhD in Medicine, Alternative Medicine, Medical Science, Pharmaceutical Science, Nursing, Life Sciences, Biological Sciences, or related disciplines.
Relevant and equivalent experience may be considered in lieu of formal educational requirements.
Experience Required
Minimum 2+ years of experience in the pharmaceutical, biotechnology, or CRO industry.
Hands-on experience in pharmacovigilance, safety writing, case processing, or quality/peer review.
Strong understanding of medical and drug terminology.
Knowledge of GCP, GVP, ICH guidelines, and global regulatory reporting requirements.
Experience with regulatory submissions for both investigational and marketed products.
Proficiency in Microsoft Office applications.
Preferred Qualifications
Experience in generating quality metrics, conducting trend analysis, and coordinating CAPA activities.
Working knowledge of medical device reporting requirements.
Work Environment
Office-based or remote working arrangement.
Ability to travel up to 10%, including overnight travel as required.
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