Fortrea Careers: Apply Now for Quality Associate Role
Fortrea Careers: Fortrea is seeking a detail-oriented Functional Quality Associate II to support global Pharmacovigilance (PV) and quality review activities. This role is ideal for professionals with strong experience in safety operations, case quality review, and compliance who want to be part of a rapidly advancing CRO environment. As part of Fortrea’s Quality team, you will help ensure delivery of compliant, accurate, and timely safety data—directly supporting regulatory submissions and patient safety worldwide.
Fortrea Careers—Job Details
- Position: Functional Quality Associate II
- Department: Process Compliance Review & Analysis
- Location: Pune (Hybrid)
About the Company
Fortrea is a global clinical research organization advancing next-generation solutions across the drug development lifecycle. With a focus on scientific rigor, data integrity, and operational excellence, Fortrea partners with leading pharmaceutical and biotech companies worldwide. The team is committed to supporting regulatory compliance, improving safety outcomes, and accelerating access to life-saving therapies.
Fortrea Careers-Qualifications
Minimum Required:
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Bachelor’s/Master’s/PhD in Medicine, Alternative Medicine, Medical Science, or related fields
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Minimum 2+ years of experience in pharmacovigilance/safety writing, Peer review, or Quality review in pharma, biotech, or CRO sectors
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Strong understanding of:
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Medical & drug terminology, ICH guidelines, GCP, GVP, regulatory reporting requirements (FDA, EU), case processing, and safety assessment.
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Proficiency in MS Office
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Ability to identify issues, propose solutions, and coordinate cross-functional activities
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Preferred:
- Experience generating quality metrics, trend reports, and CAPA documentation
- Experience assessing case quality from medical and scientific perspectives
- Knowledge of medical device reporting
Role Overview
The Functional Quality Associate II is responsible for ensuring the accuracy, quality, and regulatory compliance of safety deliverables. The role supports multiple safety operations, including expedited reporting, quality checks, training coordination, CAPA management, and preparation for internal/external audits.
Key Responsibilities
Quality Review & Compliance
- Conduct quality review of safety reports and case narratives.
- Perform sample-based QC of cases submitted for global regulatory authorities (IND reports, PSURs, PADERs, CDS, USPI, SPC, MedGuides, etc.).
- Assist in client quality reviews, trend analysis, and quality metrics preparation.
- Support CAPA development, documentation, and implementation alongside project managers.
Safety Data Management
- Review expedited adverse events, product quality complaints (PQCs), and medical information (MI) queries.
- Manage and confirm timely submission to clients or regulatory bodies when required.
- Handle intake review, call documentation, and case follow-up.
- Respond to MI queries and PQCs via email, phone, or other channels as per SOPs.
Training & Project Support
- Assist in designing and tracking training schedules for new hires and ongoing teams.
- Participate in discussion forums to highlight quality errors and propose process improvements.
- Support preparation for client audits and regulatory inspections.
- Contribute to quality management plan development.
Process Improvement & Coordination
- Analyze data, identify process gaps, and recommend improvements.
- Reconcile data across multiple systems and support tracking of key project metrics.
- Support safety associates with voice call handling when required.
Audit & Inspection Readiness
- Coordinate with project teams to support clients during regulatory audits.
- Ensure required documentation, quality evidence, and compliance records are maintained.
